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ANNE Chest

Model 810-00012 · Sibel Health Inc. · DI 00860004541745

BZQ — Monitor, Breathing Frequency · Class II · 21 CFR 868.2375

DRG — Transmitters And Receivers, Physiological Signal, Radiofrequency · Class II · 21 CFR 870.2910

FLL — Continuous Measurement Thermometer · Class II · 21 CFR 880.2910

KMI — Monitor, Bed Patient · Class I · 21 CFR 880.2400

MWI — Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) · Class II · 21 CFR 870.2300

MWJ — Electrocardiograph, Ambulatory (Without Analysis) · Class II · 21 CFR 870.2800

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.

13452019-01: 0 reports for this device; peer average 2.8/device2019-02: 0 reports for this device; peer average 2/device2019-03: 0 reports for this device; peer average 1.88/device2019-04: 0 reports for this device; peer average 5.1/device2019-05: 0 reports for this device; peer average 3/device2019-06: 0 reports for this device; peer average 2/device2019-07: 0 reports for this device; peer average 2.53/device2019-08: 0 reports for this device; peer average 2.14/device2019-09: 0 reports for this device; peer average 2.83/device2019-10: 0 reports for this device; peer average 2.41/device2019-11: 0 reports for this device; peer average 1.36/device2019-12: 0 reports for this device; peer average 2.14/device2020-01: 0 reports for this device; peer average 2.5/device2020-02: 0 reports for this device; peer average 2.71/device2020-03: 0 reports for this device; peer average 3.08/device2020-04: 0 reports for this device; peer average 2.71/device2020-05: 0 reports for this device; peer average 2.67/device2020-06: 0 reports for this device; peer average 2.16/device2020-07: 0 reports for this device; peer average 2.88/device2020-08: 0 reports for this device; peer average 3.23/device2020-09: 0 reports for this device; peer average 2.58/device2020-10: 0 reports for this device; peer average 3.78/device2020-11: 0 reports for this device; peer average 3.83/device2020-12: 0 reports for this device; peer average 3/device2021-01: 0 reports for this device; peer average 1.57/device2021-02: 0 reports for this device; peer average 2.87/device2021-03: 0 reports for this device; peer average 2.5/device2021-04: 0 reports for this device; peer average 4.24/device2021-05: 0 reports for this device; peer average 3.44/device2021-06: 0 reports for this device; peer average 2/device2021-07: 0 reports for this device; peer average 2.3/device2021-08: 0 reports for this device; peer average 4.48/device2021-09: 0 reports for this device; peer average 3.8/device2021-10: 0 reports for this device; peer average 3/device2021-11: 0 reports for this device; peer average 2.88/device2021-12: 0 reports for this device; peer average 4.53/device2022-01: 0 reports for this device; peer average 2.61/device2022-02: 0 reports for this device; peer average 2.13/device2022-03: 0 reports for this device; peer average 2.96/device2022-04: 0 reports for this device; peer average 2.41/device2022-05: 0 reports for this device; peer average 3.6/device2022-06: 0 reports for this device; peer average 2.42/device2022-07: 0 reports for this device; peer average 2.89/device2022-08: 0 reports for this device; peer average 2.21/device2022-09: 0 reports for this device; peer average 2.39/device2022-10: 0 reports for this device; peer average 2.32/device2022-11: 0 reports for this device; peer average 2.4/device2022-12: 0 reports for this device; peer average 2.04/device2023-01: 0 reports for this device; peer average 2.06/device2023-02: 0 reports for this device; peer average 2.86/device2023-03: 0 reports for this device; peer average 2.96/device2023-04: 0 reports for this device; peer average 2.95/device2023-05: 0 reports for this device; peer average 2.52/device2023-06: 0 reports for this device; peer average 3.33/device2023-07: 0 reports for this device; peer average 2.85/device2023-08: 0 reports for this device; peer average 2.67/device2023-09: 0 reports for this device; peer average 3.38/device2023-10: 0 reports for this device; peer average 2.14/device2023-11: 0 reports for this device; peer average 3.13/device2023-12: 0 reports for this device; peer average 2.28/device2024-01: 0 reports for this device; peer average 4.47/device2024-02: 0 reports for this device; peer average 2/device2024-03: 0 reports for this device; peer average 2.16/device2024-04: 0 reports for this device; peer average 2.47/device2024-05: 0 reports for this device; peer average 4.71/device2024-06: 0 reports for this device; peer average 2.52/device2024-07: 0 reports for this device; peer average 3.52/device2024-08: 0 reports for this device; peer average 3.79/device2024-09: 0 reports for this device; peer average 2.41/device2024-10: 0 reports for this device; peer average 2.95/device2024-11: 0 reports for this device; peer average 2.93/device2024-12: 0 reports for this device; peer average 4.5/device2025-01: 0 reports for this device; peer average 2.32/device2025-02: 0 reports for this device; peer average 4.1/device2025-03: 0 reports for this device; peer average 1.95/device2025-04: 0 reports for this device; peer average 2.28/device2025-05: 0 reports for this device; peer average 2.86/device2025-06: 0 reports for this device; peer average 2.67/device2025-07: 0 reports for this device; peer average 3.64/device2025-08: 0 reports for this device; peer average 4.65/device2025-09: 0 reports for this device; peer average 4.41/device2025-10: 0 reports for this device; peer average 5/device2025-11: 0 reports for this device; peer average 4.25/device2025-12: 0 reports for this device; peer average 3.83/device2026-01: 0 reports for this device; peer average 3.18/device2026-02: 0 reports for this device; peer average 3.16/device2026-03: 0 reports for this device; peer average 4.21/device2026-04: 0 reports for this device; peer average 4.85/device2026-05: 0 reports for this device; peer average 5.32/device2026-06: 0 reports for this device; peer average 4.39/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
2019-0202
2019-0301.88
2019-0405.1
2019-0503
2019-0602
2019-0702.53
2019-0802.14
2019-0902.83
2019-1002.41
2019-1101.36
2019-1202.14
2020-0102.5
2020-0202.71
2020-0303.08
2020-0402.71
2020-0502.67
2020-0602.16
2020-0702.88
2020-0803.23
2020-0902.58
2020-1003.78
2020-1103.83
2020-1203
2021-0101.57
2021-0202.87
2021-0302.5
2021-0404.24
2021-0503.44
2021-0602
2021-0702.3
2021-0804.48
2021-0903.8
2021-1003
2021-1102.88
2021-1204.53
2022-0102.61
2022-0202.13
2022-0302.96
2022-0402.41
2022-0503.6
2022-0602.42
2022-0702.89
2022-0802.21
2022-0902.39
2022-1002.32
2022-1102.4
2022-1202.04
2023-0102.06
2023-0202.86
2023-0302.96
2023-0402.95
2023-0502.52
2023-0603.33
2023-0702.85
2023-0802.67
2023-0903.38
2023-1002.14
2023-1103.13
2023-1202.28
2024-0104.47
2024-0202
2024-0302.16
2024-0402.47
2024-0504.71
2024-0602.52
2024-0703.52
2024-0803.79
2024-0902.41
2024-1002.95
2024-1102.93
2024-1204.5
2025-0102.32
2025-0204.1
2025-0301.95
2025-0402.28
2025-0502.86
2025-0602.67
2025-0703.64
2025-0804.65
2025-0904.41
2025-1005
2025-1104.25
2025-1203.83
2026-0103.18
2026-0203.16
2026-0304.21
2026-0404.85
2026-0505.32
2026-0604.39
This device (reports/month)Average device in BZQ, DRG, FLL, KMI, MWI, MWJ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K240251 — cites (transitively): K223711 (d1), K230626 (d1), K141877 (d2), K191614 (d2), K211305 (d2), K212317 (d2), K220095 (d2), K171121 (d2), K180472 (d2), K213234 (d2), K071047 (d3), K103604 (d3), K151644 (d3), K980327 (d3), K052160 (d3), K062282 (d3), K142827 (d3), K143751 (d3), K150361 (d3), K152341 (d3), K162137 (d3), K172329 (d3), K001025 (d3), K011837 (d3), K110001 (d3), K152881 (d3), K201921 (d3), K110028 (d3), K182868 (d3), K190008 (d3), K191149 (d3), K191249 (d3), K191323 (d3), K200494 (d3), K183559 (d3), K051092 (d4), K042745 (d4), K993620 (d4), K100428 (d4), K122036 (d4), K130709 (d4), K133586 (d4), K051874 (d4), K090989 (d4), K101680 (d4), K142394 (d4), K130339 (d4), K062397 (d4), K130155 (d4), K132761 (d4), K143267 (d4), K152139 (d4), K082327 (d4), K180775 (d4), K011000 (d4), K022834 (d4), K051367 (d4), K053174 (d4), K071073 (d4), K080251 (d4), K083750 (d4), K132533 (d4), K151063 (d4), K171580 (d4), K172482 (d4), K900598 (d4), K131223 (d4), K150245 (d4), K131414 (d4), K080238 (d5), K091241 (d5), K040490 (d5), K002725 (d5), K022453 (d5), K033378 (d5), K103634 (d5), K082599 (d5), K102239 (d5), K092027 (d5), K121696 (d5), K140188 (d5), K063542 (d5), K123195 (d5), K032582 (d5), K052582 (d5), K053269 (d5), K060576 (d5), K061907 (d5), K133576 (d5), K133882 (d5), K150298 (d5), K141167 (d5), K042346 (d5), K042536 (d5), K051212 (d5), K162012 (d5), K141518 (d5), K161579 (d5), K061185 (d6), K092680 (d6), K100226 (d6), K062976 (d6), K092369 (d6), K110132 (d6), K842308 (d6), K121013 (d6), K083287 (d6), K132447 (d6), K111933 (d6), K121806 (d6), K123581 (d6), K130320 (d6), K062580 (d6), K082540 (d6), K103129 (d6), K122516 (d6), K133859 (d6), K060833 (d7), K050463 (d7), K081256 (d7), K072502 (d7), K083639 (d7), K051896 (d7), K083325 (d7), K041904 (d7), K073682 (d7), K012891 (d7), K120773 (d7) — cited as predicate by K243183, K243837

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

Manufacturer compliance record — Sibel Health Inc.

  • NAI 2022-11-18 Sibel Inc. · 0 citations