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ANNE Bedside Wireless Charger

Model 900-00008 · Sibel Health Inc. · DI 00850064210057

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

DQA — Oximeter · Class II · 21 CFR 870.2700

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.

71421282019-01: 0 reports for this device; peer average 9.75/device2019-02: 0 reports for this device; peer average 10.41/device2019-03: 0 reports for this device; peer average 7.69/device2019-04: 0 reports for this device; peer average 8.71/device2019-05: 0 reports for this device; peer average 7.2/device2019-06: 0 reports for this device; peer average 6.02/device2019-07: 0 reports for this device; peer average 6.33/device2019-08: 0 reports for this device; peer average 7.4/device2019-09: 0 reports for this device; peer average 10.55/device2019-10: 0 reports for this device; peer average 7.26/device2019-11: 0 reports for this device; peer average 7.24/device2019-12: 0 reports for this device; peer average 8.64/device2020-01: 0 reports for this device; peer average 7.92/device2020-02: 0 reports for this device; peer average 7.1/device2020-03: 0 reports for this device; peer average 7.5/device2020-04: 0 reports for this device; peer average 11.4/device2020-05: 0 reports for this device; peer average 7.78/device2020-06: 0 reports for this device; peer average 6.33/device2020-07: 0 reports for this device; peer average 6.6/device2020-08: 0 reports for this device; peer average 7.27/device2020-09: 0 reports for this device; peer average 8.56/device2020-10: 0 reports for this device; peer average 8.51/device2020-11: 0 reports for this device; peer average 9.59/device2020-12: 0 reports for this device; peer average 9.57/device2021-01: 0 reports for this device; peer average 9.05/device2021-02: 0 reports for this device; peer average 8.97/device2021-03: 0 reports for this device; peer average 10.49/device2021-04: 0 reports for this device; peer average 7.87/device2021-05: 0 reports for this device; peer average 6.59/device2021-06: 0 reports for this device; peer average 7.81/device2021-07: 0 reports for this device; peer average 6.41/device2021-08: 0 reports for this device; peer average 6.82/device2021-09: 0 reports for this device; peer average 6.54/device2021-10: 0 reports for this device; peer average 7.68/device2021-11: 0 reports for this device; peer average 7.91/device2021-12: 0 reports for this device; peer average 6.98/device2022-01: 0 reports for this device; peer average 5.79/device2022-02: 0 reports for this device; peer average 6.86/device2022-03: 0 reports for this device; peer average 8.54/device2022-04: 0 reports for this device; peer average 8.09/device2022-05: 0 reports for this device; peer average 11.38/device2022-06: 0 reports for this device; peer average 8.19/device2022-07: 0 reports for this device; peer average 5.88/device2022-08: 0 reports for this device; peer average 7.54/device2022-09: 0 reports for this device; peer average 9.55/device2022-10: 0 reports for this device; peer average 12.14/device2022-11: 0 reports for this device; peer average 7.89/device2022-12: 0 reports for this device; peer average 8.74/device2023-01: 0 reports for this device; peer average 7.97/device2023-02: 0 reports for this device; peer average 13.98/device2023-03: 0 reports for this device; peer average 14.79/device2023-04: 0 reports for this device; peer average 16.3/device2023-05: 0 reports for this device; peer average 16.08/device2023-06: 0 reports for this device; peer average 11.74/device2023-07: 0 reports for this device; peer average 22.42/device2023-08: 0 reports for this device; peer average 23.71/device2023-09: 0 reports for this device; peer average 25.51/device2023-10: 0 reports for this device; peer average 16.06/device2023-11: 0 reports for this device; peer average 23.66/device2023-12: 0 reports for this device; peer average 20.46/device2024-01: 0 reports for this device; peer average 23/device2024-02: 0 reports for this device; peer average 17.72/device2024-03: 0 reports for this device; peer average 22.35/device2024-04: 0 reports for this device; peer average 13.41/device2024-05: 0 reports for this device; peer average 14.1/device2024-06: 0 reports for this device; peer average 11.92/device2024-07: 0 reports for this device; peer average 19.37/device2024-08: 0 reports for this device; peer average 18.85/device2024-09: 0 reports for this device; peer average 23.4/device2024-10: 0 reports for this device; peer average 28.04/device2024-11: 0 reports for this device; peer average 19.59/device2024-12: 0 reports for this device; peer average 16.05/device2025-01: 0 reports for this device; peer average 20.15/device2025-02: 0 reports for this device; peer average 16.99/device2025-03: 0 reports for this device; peer average 19.67/device2025-04: 0 reports for this device; peer average 12.99/device2025-05: 0 reports for this device; peer average 11.38/device2025-06: 0 reports for this device; peer average 8.13/device2025-07: 0 reports for this device; peer average 8.31/device2025-08: 0 reports for this device; peer average 7.4/device2025-09: 0 reports for this device; peer average 7.73/device2025-10: 0 reports for this device; peer average 10.74/device2025-11: 0 reports for this device; peer average 7.07/device2025-12: 0 reports for this device; peer average 8.43/device2026-01: 0 reports for this device; peer average 7.95/device2026-02: 0 reports for this device; peer average 7.76/device2026-03: 0 reports for this device; peer average 9.3/device2026-04: 0 reports for this device; peer average 22.44/device2026-05: 0 reports for this device; peer average 12.2/device2026-06: 0 reports for this device; peer average 9.72/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0109.75
2019-02010.41
2019-0307.69
2019-0408.71
2019-0507.2
2019-0606.02
2019-0706.33
2019-0807.4
2019-09010.55
2019-1007.26
2019-1107.24
2019-1208.64
2020-0107.92
2020-0207.1
2020-0307.5
2020-04011.4
2020-0507.78
2020-0606.33
2020-0706.6
2020-0807.27
2020-0908.56
2020-1008.51
2020-1109.59
2020-1209.57
2021-0109.05
2021-0208.97
2021-03010.49
2021-0407.87
2021-0506.59
2021-0607.81
2021-0706.41
2021-0806.82
2021-0906.54
2021-1007.68
2021-1107.91
2021-1206.98
2022-0105.79
2022-0206.86
2022-0308.54
2022-0408.09
2022-05011.38
2022-0608.19
2022-0705.88
2022-0807.54
2022-0909.55
2022-10012.14
2022-1107.89
2022-1208.74
2023-0107.97
2023-02013.98
2023-03014.79
2023-04016.3
2023-05016.08
2023-06011.74
2023-07022.42
2023-08023.71
2023-09025.51
2023-10016.06
2023-11023.66
2023-12020.46
2024-01023
2024-02017.72
2024-03022.35
2024-04013.41
2024-05014.1
2024-06011.92
2024-07019.37
2024-08018.85
2024-09023.4
2024-10028.04
2024-11019.59
2024-12016.05
2025-01020.15
2025-02016.99
2025-03019.67
2025-04012.99
2025-05011.38
2025-0608.13
2025-0708.31
2025-0807.4
2025-0907.73
2025-10010.74
2025-1107.07
2025-1208.43
2026-0107.95
2026-0207.76
2026-0309.3
2026-04022.44
2026-05012.2
2026-0609.72
This device (reports/month)Average device in BZQ, DQA, DRG, FLL, KMI, MWI, MWJ (reports/device/month)

Regulatory clearances

  • K240305 SESE 2024-05-28 (k number procode)

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

K240305 — cites (transitively): K223711 (d1), K141877 (d2), K191614 (d2), K211305 (d2), K212317 (d2), K220095 (d2), K162137 (d3), K172329 (d3), K001025 (d3), K011837 (d3), K110001 (d3), K152881 (d3), K201921 (d3), K183559 (d3), K042745 (d4), K993620 (d4), K062397 (d4), K130155 (d4), K132761 (d4), K143267 (d4), K152139 (d4), K180775 (d4), K121696 (d5), K063542 (d5), K141167 (d5), K161579 (d5), K100226 (d6), K083287 (d6), K132447 (d6), K122516 (d6), K133859 (d6), K050463 (d7), K081256 (d7), K041904 (d7), K073682 (d7) — cited as predicate by K243837

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

Manufacturer compliance record — Sibel Health Inc.

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