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"HotDog Underbody Warming Mattress + Return Electrode, 127 cm (50"")"

Model U502 · AUGUSTINE TEMPERATURE MANAGEMENT LLC · DI 00855913001824

DWJ — System, Thermal Regulating · Class II · 21 CFR 870.5900

GEI — Electrosurgical, Cutting & Coagulation & Accessories · Class II · 21 CFR 878.4400

UDILibrary device dossier · generated 2026-09-13 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (5)

InitiatedRecall #ClassStatusReasonLink basis
2024-12-16Z-1197-2025Class IIOpen, ClassifiedThere is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the mattress can experience the same type of deflection that caused the intermittent connection with the cables connecting to the ESU.k number procode
2024-12-16Z-1198-2025Class IIOpen, ClassifiedThere is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the mattress can experience the same type of deflection that caused the intermittent connection with the cables connecting to the ESU.code info di
2024-12-16Z-1199-2025Class IIOpen, ClassifiedThere is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the mattress can experience the same type of deflection that caused the intermittent connection with the cables connecting to the ESU.k number procode
2024-02-15Z-1171-2025Class IIOpen, ClassifiedUsers were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact .k number procode
2024-02-15Z-1172-2025Class IIOpen, ClassifiedUsers were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact .k number procode

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

24572019-01: 0 reports for this device; peer average 7.32/device2019-02: 0 reports for this device; peer average 4.73/device2019-03: 0 reports for this device; peer average 4.84/device2019-04: 0 reports for this device; peer average 6.52/device2019-05: 0 reports for this device; peer average 5.17/device2019-06: 0 reports for this device; peer average 5.52/device2019-07: 0 reports for this device; peer average 6.42/device2019-08: 0 reports for this device; peer average 6.75/device2019-09: 0 reports for this device; peer average 5.76/device2019-10: 0 reports for this device; peer average 6.59/device2019-11: 0 reports for this device; peer average 6.35/device2019-12: 0 reports for this device; peer average 6.15/device2020-01: 0 reports for this device; peer average 5.67/device2020-02: 0 reports for this device; peer average 6.41/device2020-03: 0 reports for this device; peer average 6.26/device2020-04: 0 reports for this device; peer average 4.25/device2020-05: 0 reports for this device; peer average 4.68/device2020-06: 0 reports for this device; peer average 5.92/device2020-07: 0 reports for this device; peer average 7.19/device2020-08: 0 reports for this device; peer average 5.39/device2020-09: 0 reports for this device; peer average 6.53/device2020-10: 0 reports for this device; peer average 6.03/device2020-11: 0 reports for this device; peer average 5.69/device2020-12: 0 reports for this device; peer average 6.1/device2021-01: 0 reports for this device; peer average 5.72/device2021-02: 0 reports for this device; peer average 5.58/device2021-03: 0 reports for this device; peer average 6.36/device2021-04: 0 reports for this device; peer average 5.71/device2021-05: 0 reports for this device; peer average 5.61/device2021-06: 0 reports for this device; peer average 6.47/device2021-07: 0 reports for this device; peer average 5.36/device2021-08: 0 reports for this device; peer average 4.9/device2021-09: 0 reports for this device; peer average 5.39/device2021-10: 0 reports for this device; peer average 6.6/device2021-11: 0 reports for this device; peer average 6.25/device2021-12: 0 reports for this device; peer average 6.6/device2022-01: 0 reports for this device; peer average 5.47/device2022-02: 0 reports for this device; peer average 5.59/device2022-03: 0 reports for this device; peer average 6.34/device2022-04: 0 reports for this device; peer average 5.83/device2022-05: 0 reports for this device; peer average 6.87/device2022-06: 0 reports for this device; peer average 7.2/device2022-07: 0 reports for this device; peer average 5.59/device2022-08: 0 reports for this device; peer average 5.76/device2022-09: 0 reports for this device; peer average 5.62/device2022-10: 0 reports for this device; peer average 5.44/device2022-11: 0 reports for this device; peer average 5.76/device2022-12: 0 reports for this device; peer average 5.09/device2023-01: 0 reports for this device; peer average 6.51/device2023-02: 0 reports for this device; peer average 5.29/device2023-03: 0 reports for this device; peer average 5.67/device2023-04: 0 reports for this device; peer average 5.21/device2023-05: 0 reports for this device; peer average 5.85/device2023-06: 0 reports for this device; peer average 5.44/device2023-07: 0 reports for this device; peer average 5.52/device2023-08: 0 reports for this device; peer average 5.07/device2023-09: 0 reports for this device; peer average 5.95/device2023-10: 0 reports for this device; peer average 5.48/device2023-11: 0 reports for this device; peer average 4.99/device2023-12: 0 reports for this device; peer average 5.47/device2024-01: 0 reports for this device; peer average 6.11/device2024-02: 0 reports for this device; peer average 6.3/device2024-03: 0 reports for this device; peer average 6.59/device2024-04: 0 reports for this device; peer average 6.41/device2024-05: 0 reports for this device; peer average 6.6/device2024-06: 0 reports for this device; peer average 5.64/device2024-07: 0 reports for this device; peer average 5.39/device2024-08: 0 reports for this device; peer average 5.59/device2024-09: 0 reports for this device; peer average 6.07/device2024-10: 0 reports for this device; peer average 6.04/device2024-11: 0 reports for this device; peer average 5.58/device2024-12: 0 reports for this device; peer average 4.36/device2025-01: 0 reports for this device; peer average 5.5/device2025-02: 0 reports for this device; peer average 4.75/device2025-03: 0 reports for this device; peer average 6.34/device2025-04: 0 reports for this device; peer average 4.64/device2025-05: 0 reports for this device; peer average 5.38/device2025-06: 0 reports for this device; peer average 5.34/device2025-07: 0 reports for this device; peer average 5.42/device2025-08: 0 reports for this device; peer average 5.6/device2025-09: 0 reports for this device; peer average 5.11/device2025-10: 0 reports for this device; peer average 5.44/device2025-11: 0 reports for this device; peer average 5.71/device2025-12: 0 reports for this device; peer average 5.94/device2026-01: 0 reports for this device; peer average 5.64/device2026-02: 0 reports for this device; peer average 6.22/device2026-03: 0 reports for this device; peer average 6.37/device2026-04: 0 reports for this device; peer average 5.53/device2026-05: 0 reports for this device; peer average 6.22/device2026-06: 0 reports for this device; peer average 5.65/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0107.32
2019-0204.73
2019-0304.84
2019-0406.52
2019-0505.17
2019-0605.52
2019-0706.42
2019-0806.75
2019-0905.76
2019-1006.59
2019-1106.35
2019-1206.15
2020-0105.67
2020-0206.41
2020-0306.26
2020-0404.25
2020-0504.68
2020-0605.92
2020-0707.19
2020-0805.39
2020-0906.53
2020-1006.03
2020-1105.69
2020-1206.1
2021-0105.72
2021-0205.58
2021-0306.36
2021-0405.71
2021-0505.61
2021-0606.47
2021-0705.36
2021-0804.9
2021-0905.39
2021-1006.6
2021-1106.25
2021-1206.6
2022-0105.47
2022-0205.59
2022-0306.34
2022-0405.83
2022-0506.87
2022-0607.2
2022-0705.59
2022-0805.76
2022-0905.62
2022-1005.44
2022-1105.76
2022-1205.09
2023-0106.51
2023-0205.29
2023-0305.67
2023-0405.21
2023-0505.85
2023-0605.44
2023-0705.52
2023-0805.07
2023-0905.95
2023-1005.48
2023-1104.99
2023-1205.47
2024-0106.11
2024-0206.3
2024-0306.59
2024-0406.41
2024-0506.6
2024-0605.64
2024-0705.39
2024-0805.59
2024-0906.07
2024-1006.04
2024-1105.58
2024-1204.36
2025-0105.5
2025-0204.75
2025-0306.34
2025-0404.64
2025-0505.38
2025-0605.34
2025-0705.42
2025-0805.6
2025-0905.11
2025-1005.44
2025-1105.71
2025-1205.94
2026-0105.64
2026-0206.22
2026-0306.37
2026-0405.53
2026-0506.22
2026-0605.65
This device (reports/month)Average device in DWJ, GEI (reports/device/month)

Regulatory clearances

  • K232627 SESE 2024-04-18 (k number procode)
  • K230866 SESE 2023-06-29 (k number procode)

Predicate lineage

K230866 — cites (transitively): K210727 (d1), K220941 (d1), K133726 (d2), K180834 (d2), K201779 (d2), K152266 (d3), K052392 (d3), K094056 (d3), K092807 (d4), K100585 (d4), K003349 (d5), K071341 (d5), K083662 (d5) — cited as predicate by K232627

K232627 — cites (transitively): K031285 (d1), K230866 (d1), K210727 (d2), K220941 (d2), K133726 (d3), K180834 (d3), K201779 (d3), K152266 (d4), K052392 (d4), K094056 (d4), K092807 (d5), K100585 (d5), K003349 (d6), K071341 (d6), K083662 (d6)

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — AUGUSTINE TEMPERATURE MANAGEMENT LLC

  • Warning Letter 2024-03-21 Augustine Temperature Management, LLC
  • Warning Letter 2024-03-21 Augustine Temperature Management, LLC
  • Warning Letter 2012-07-24 Augustine Temperature Management, LLC
  • Warning Letter 2012-07-24 Augustine Temperature Management, LLC
  • OAI 2024-11-27 Augustine Temperature Management, LLC · 5 citations
  • OAI 2024-11-27 Augustine Temperature Management, LLC · 5 citations
  • OAI 2023-09-19 Augustine Temperature Management, LLC · 2 citations
  • OAI 2023-09-19 Augustine Temperature Management, LLC · 2 citations
  • VAI 2017-01-04 Augustine Temperature Management, LLC · 3 citations
  • VAI 2017-01-04 Augustine Temperature Management, LLC · 3 citations
  • NAI 2012-09-26 Augustine Temperature Management, LLC · 0 citations
  • NAI 2012-09-26 Augustine Temperature Management, LLC · 0 citations
  • VAI 2010-07-14 Augustine Temperature Management, LLC · 7 citations
  • VAI 2010-07-14 Augustine Temperature Management, LLC · 7 citations