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MEDLINE

Model HCS07GS · MEDLINE INDUSTRIES, INC. · DI 10197344162550

CCK — Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase · Class II · 21 CFR 868.1400

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 (0)

No recalls linked in the loaded window.

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.

47931401862019-01: 0 reports for this device; peer average 2.8/device2019-02: 0 reports for this device; peer average 1.29/device2019-03: 0 reports for this device; peer average 1.2/device2019-04: 0 reports for this device; peer average 1.71/device2019-05: 0 reports for this device; peer average 1.91/device2019-06: 0 reports for this device; peer average 1.5/device2019-07: 0 reports for this device; peer average 1.8/device2019-08: 0 reports for this device; peer average 2.33/device2019-09: 0 reports for this device; peer average 1.85/device2019-10: 0 reports for this device; peer average 2.2/device2019-11: 0 reports for this device; peer average 2.44/device2019-12: 0 reports for this device; peer average 3.29/device2020-01: 0 reports for this device; peer average 1.8/device2020-02: 0 reports for this device; peer average 2/device2020-03: 0 reports for this device; peer average 3.2/device2020-04: 0 reports for this device; peer average 1.83/device2020-05: 0 reports for this device; peer average 1.5/device2020-06: 0 reports for this device; peer average 3/device2020-07: 0 reports for this device; peer average 2.17/device2020-08: 0 reports for this device; peer average 4.4/device2020-09: 0 reports for this device; peer average 19.25/device2020-10: 0 reports for this device; peer average 19.67/device2020-11: 0 reports for this device; peer average 60.38/device2020-12: 0 reports for this device; peer average 186/device2021-01: 0 reports for this device; peer average 111/device2021-02: 0 reports for this device; peer average 13.75/device2021-03: 0 reports for this device; peer average 9.56/device2021-04: 0 reports for this device; peer average 6.54/device2021-05: 0 reports for this device; peer average 9.43/device2021-06: 0 reports for this device; peer average 17.33/device2021-07: 0 reports for this device; peer average 16.89/device2021-08: 0 reports for this device; peer average 11/device2021-09: 0 reports for this device; peer average 9.8/device2021-10: 0 reports for this device; peer average 15.37/device2021-11: 0 reports for this device; peer average 15.92/device2021-12: 0 reports for this device; peer average 38.83/device2022-01: 0 reports for this device; peer average 31/device2022-02: 0 reports for this device; peer average 23.38/device2022-03: 0 reports for this device; peer average 38.75/device2022-04: 0 reports for this device; peer average 21.5/device2022-05: 0 reports for this device; peer average 20.89/device2022-06: 0 reports for this device; peer average 17.8/device2022-07: 0 reports for this device; peer average 20.5/device2022-08: 0 reports for this device; peer average 13.74/device2022-09: 0 reports for this device; peer average 16/device2022-10: 0 reports for this device; peer average 14.92/device2022-11: 0 reports for this device; peer average 18/device2022-12: 0 reports for this device; peer average 29.38/device2023-01: 0 reports for this device; peer average 14.7/device2023-02: 0 reports for this device; peer average 22/device2023-03: 0 reports for this device; peer average 22.25/device2023-04: 0 reports for this device; peer average 28.75/device2023-05: 0 reports for this device; peer average 25.5/device2023-06: 0 reports for this device; peer average 20.89/device2023-07: 0 reports for this device; peer average 15.09/device2023-08: 0 reports for this device; peer average 19.29/device2023-09: 0 reports for this device; peer average 12.58/device2023-10: 0 reports for this device; peer average 16/device2023-11: 0 reports for this device; peer average 13.33/device2023-12: 0 reports for this device; peer average 6.18/device2024-01: 0 reports for this device; peer average 9.29/device2024-02: 0 reports for this device; peer average 20.18/device2024-03: 0 reports for this device; peer average 17.58/device2024-04: 0 reports for this device; peer average 9.14/device2024-05: 0 reports for this device; peer average 7/device2024-06: 0 reports for this device; peer average 9.14/device2024-07: 0 reports for this device; peer average 10.54/device2024-08: 0 reports for this device; peer average 12.54/device2024-09: 0 reports for this device; peer average 16.7/device2024-10: 0 reports for this device; peer average 11.76/device2024-11: 0 reports for this device; peer average 8.86/device2024-12: 0 reports for this device; peer average 17.89/device2025-01: 0 reports for this device; peer average 8.11/device2025-02: 0 reports for this device; peer average 9.6/device2025-03: 0 reports for this device; peer average 11.11/device2025-04: 0 reports for this device; peer average 14.31/device2025-05: 0 reports for this device; peer average 11.39/device2025-06: 0 reports for this device; peer average 10.14/device2025-07: 0 reports for this device; peer average 23.13/device2025-08: 0 reports for this device; peer average 10/device2025-09: 0 reports for this device; peer average 7.7/device2025-10: 0 reports for this device; peer average 12.53/device2025-11: 0 reports for this device; peer average 11/device2025-12: 0 reports for this device; peer average 16.29/device2026-01: 0 reports for this device; peer average 11.4/device2026-02: 0 reports for this device; peer average 16.38/device2026-03: 0 reports for this device; peer average 10.64/device2026-04: 0 reports for this device; peer average 14.65/device2026-05: 0 reports for this device; peer average 26/device2026-06: 0 reports for this device; peer average 49.6/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.8
2019-0201.29
2019-0301.2
2019-0401.71
2019-0501.91
2019-0601.5
2019-0701.8
2019-0802.33
2019-0901.85
2019-1002.2
2019-1102.44
2019-1203.29
2020-0101.8
2020-0202
2020-0303.2
2020-0401.83
2020-0501.5
2020-0603
2020-0702.17
2020-0804.4
2020-09019.25
2020-10019.67
2020-11060.38
2020-120186
2021-010111
2021-02013.75
2021-0309.56
2021-0406.54
2021-0509.43
2021-06017.33
2021-07016.89
2021-08011
2021-0909.8
2021-10015.37
2021-11015.92
2021-12038.83
2022-01031
2022-02023.38
2022-03038.75
2022-04021.5
2022-05020.89
2022-06017.8
2022-07020.5
2022-08013.74
2022-09016
2022-10014.92
2022-11018
2022-12029.38
2023-01014.7
2023-02022
2023-03022.25
2023-04028.75
2023-05025.5
2023-06020.89
2023-07015.09
2023-08019.29
2023-09012.58
2023-10016
2023-11013.33
2023-1206.18
2024-0109.29
2024-02020.18
2024-03017.58
2024-0409.14
2024-0507
2024-0609.14
2024-07010.54
2024-08012.54
2024-09016.7
2024-10011.76
2024-1108.86
2024-12017.89
2025-0108.11
2025-0209.6
2025-03011.11
2025-04014.31
2025-05011.39
2025-06010.14
2025-07023.13
2025-08010
2025-0907.7
2025-10012.53
2025-11011
2025-12016.29
2026-01011.4
2026-02016.38
2026-03010.64
2026-04014.65
2026-05026
2026-06049.6
This device (reports/month)Average device in CCK (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K143127 — cites (transitively): K010024 (d1), K011024 (d1), K011050 (d1), K980325 (d1), K980327 (d1)

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

Manufacturer compliance record — MEDLINE INDUSTRIES, INC.

  • Warning Letter 2026-03-26 MedLine Industries, LP (NAMIC Division)
  • Warning Letter 2024-03-18 Medline Industries, LP
  • Warning Letter 2024-03-18 Medline Industries, LP
  • Warning Letter 2020-06-11 Centurion Medical Products, LP
  • Warning Letter 2014-11-07 Excelsior Medical LLC
  • Warning Letter 2014-03-11 Medline Industries, LP
  • Warning Letter 2014-03-11 Medline Industries, LP
  • Warning Letter 2010-03-12 Medline Industries, LP
  • Warning Letter 2010-03-12 Medline Industries, LP
  • OAI 2025-12-12 MedLine Industries, LP (NAMIC Division) · 5 citations
  • NAI 2025-04-22 MICROTEK MEDICAL LLC · 0 citations
  • NAI 2024-01-29 Medline Industries LP · 0 citations
  • NAI 2024-01-29 Medline Industries LP · 0 citations
  • OAI 2024-01-22 Medline Industries, LP · 5 citations
  • OAI 2024-01-22 Medline Industries, LP · 5 citations
  • NAI 2023-11-01 Medline Industries, LP · 0 citations
  • NAI 2023-11-01 Medline Industries, LP · 0 citations
  • NAI 2023-07-26 Medline Industries LP · 0 citations
  • NAI 2023-07-26 Medline Industries LP · 0 citations
  • NAI 2023-02-10 Centurion Medical Products, LP · 0 citations
  • VAI 2022-04-06 Medline Industries, LP · 0 citations
  • VAI 2022-04-06 Medline Industries, LP · 0 citations
  • NAI 2022-04-05 Centurion Medical Products, LP · 0 citations
  • NAI 2022-03-28 Medline Industries, LP · 0 citations
  • NAI 2022-03-28 Medline Industries, LP · 0 citations
  • OAI 2019-11-01 Centurion Medical Products, LP · 5 citations
  • NAI 2019-10-17 Medline Industries LP · 0 citations
  • NAI 2019-10-17 Medline Industries LP · 0 citations
  • OAI 2019-08-20 Centurion Medical Products, LP · 5 citations