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ADVANCED PATIENT MONITOR

Model PM-2000A PRO · ADVANCED INSTRUMENTATIONS, INC. · DI B510PM2000APRO1

DQA — Oximeter · Class II · 21 CFR 870.2700

DRT — Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) · Class II · 21 CFR 870.2300

DSA — Cable, Transducer And Electrode, Patient, (Including Connector) · Class II · 21 CFR 870.2900

DSI — Detector And Alarm, Arrhythmia · Class II · 21 CFR 870.1025

DSK — Computer, Blood-Pressure · Class II · 21 CFR 870.1110

DXN — System, Measurement, Blood-Pressure, Non-Invasive · Class II · 21 CFR 870.1130

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

MHX — Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) · Class II · 21 CFR 870.1025

UDILibrary device dossier · generated 2026-09-11 · 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.

51015202019-01: 0 reports for this device; peer average 12.57/device2019-02: 0 reports for this device; peer average 10.48/device2019-03: 0 reports for this device; peer average 12.12/device2019-04: 0 reports for this device; peer average 10.11/device2019-05: 0 reports for this device; peer average 9.37/device2019-06: 0 reports for this device; peer average 8.25/device2019-07: 0 reports for this device; peer average 10.04/device2019-08: 0 reports for this device; peer average 9.22/device2019-09: 0 reports for this device; peer average 12.79/device2019-10: 0 reports for this device; peer average 10.45/device2019-11: 0 reports for this device; peer average 11.99/device2019-12: 0 reports for this device; peer average 10.86/device2020-01: 0 reports for this device; peer average 10.38/device2020-02: 0 reports for this device; peer average 10.09/device2020-03: 0 reports for this device; peer average 10.83/device2020-04: 0 reports for this device; peer average 10.9/device2020-05: 0 reports for this device; peer average 8.01/device2020-06: 0 reports for this device; peer average 8.66/device2020-07: 0 reports for this device; peer average 7.94/device2020-08: 0 reports for this device; peer average 9.71/device2020-09: 0 reports for this device; peer average 9.22/device2020-10: 0 reports for this device; peer average 9.08/device2020-11: 0 reports for this device; peer average 12.64/device2020-12: 0 reports for this device; peer average 10.39/device2021-01: 0 reports for this device; peer average 8.85/device2021-02: 0 reports for this device; peer average 9.74/device2021-03: 0 reports for this device; peer average 13.05/device2021-04: 0 reports for this device; peer average 12.09/device2021-05: 0 reports for this device; peer average 9.24/device2021-06: 0 reports for this device; peer average 10.56/device2021-07: 0 reports for this device; peer average 9.44/device2021-08: 0 reports for this device; peer average 10.37/device2021-09: 0 reports for this device; peer average 9.71/device2021-10: 0 reports for this device; peer average 8.67/device2021-11: 0 reports for this device; peer average 9.82/device2021-12: 0 reports for this device; peer average 9.2/device2022-01: 0 reports for this device; peer average 8.05/device2022-02: 0 reports for this device; peer average 8.06/device2022-03: 0 reports for this device; peer average 9.45/device2022-04: 0 reports for this device; peer average 8.74/device2022-05: 0 reports for this device; peer average 10.94/device2022-06: 0 reports for this device; peer average 7.13/device2022-07: 0 reports for this device; peer average 6.52/device2022-08: 0 reports for this device; peer average 8.37/device2022-09: 0 reports for this device; peer average 8.35/device2022-10: 0 reports for this device; peer average 11.16/device2022-11: 0 reports for this device; peer average 7.83/device2022-12: 0 reports for this device; peer average 8.76/device2023-01: 0 reports for this device; peer average 7.55/device2023-02: 0 reports for this device; peer average 12.6/device2023-03: 0 reports for this device; peer average 15.24/device2023-04: 0 reports for this device; peer average 13.19/device2023-05: 0 reports for this device; peer average 14.15/device2023-06: 0 reports for this device; peer average 11.09/device2023-07: 0 reports for this device; peer average 16.98/device2023-08: 0 reports for this device; peer average 17.51/device2023-09: 0 reports for this device; peer average 19.11/device2023-10: 0 reports for this device; peer average 12.99/device2023-11: 0 reports for this device; peer average 16.58/device2023-12: 0 reports for this device; peer average 17.07/device2024-01: 0 reports for this device; peer average 17.04/device2024-02: 0 reports for this device; peer average 14.58/device2024-03: 0 reports for this device; peer average 16.93/device2024-04: 0 reports for this device; peer average 11.31/device2024-05: 0 reports for this device; peer average 13.85/device2024-06: 0 reports for this device; peer average 11.06/device2024-07: 0 reports for this device; peer average 13.94/device2024-08: 0 reports for this device; peer average 14.1/device2024-09: 0 reports for this device; peer average 15.69/device2024-10: 0 reports for this device; peer average 20.25/device2024-11: 0 reports for this device; peer average 15.41/device2024-12: 0 reports for this device; peer average 13.05/device2025-01: 0 reports for this device; peer average 16.82/device2025-02: 0 reports for this device; peer average 13.36/device2025-03: 0 reports for this device; peer average 16.84/device2025-04: 0 reports for this device; peer average 11.55/device2025-05: 0 reports for this device; peer average 12.21/device2025-06: 0 reports for this device; peer average 11.17/device2025-07: 0 reports for this device; peer average 12.66/device2025-08: 0 reports for this device; peer average 10.28/device2025-09: 0 reports for this device; peer average 9.03/device2025-10: 0 reports for this device; peer average 14.4/device2025-11: 0 reports for this device; peer average 10.35/device2025-12: 0 reports for this device; peer average 11.52/device2026-01: 0 reports for this device; peer average 10.65/device2026-02: 0 reports for this device; peer average 12.28/device2026-03: 0 reports for this device; peer average 12.78/device2026-04: 0 reports for this device; peer average 19.65/device2026-05: 0 reports for this device; peer average 14.89/device2026-06: 0 reports for this device; peer average 13.13/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-01012.57
2019-02010.48
2019-03012.12
2019-04010.11
2019-0509.37
2019-0608.25
2019-07010.04
2019-0809.22
2019-09012.79
2019-10010.45
2019-11011.99
2019-12010.86
2020-01010.38
2020-02010.09
2020-03010.83
2020-04010.9
2020-0508.01
2020-0608.66
2020-0707.94
2020-0809.71
2020-0909.22
2020-1009.08
2020-11012.64
2020-12010.39
2021-0108.85
2021-0209.74
2021-03013.05
2021-04012.09
2021-0509.24
2021-06010.56
2021-0709.44
2021-08010.37
2021-0909.71
2021-1008.67
2021-1109.82
2021-1209.2
2022-0108.05
2022-0208.06
2022-0309.45
2022-0408.74
2022-05010.94
2022-0607.13
2022-0706.52
2022-0808.37
2022-0908.35
2022-10011.16
2022-1107.83
2022-1208.76
2023-0107.55
2023-02012.6
2023-03015.24
2023-04013.19
2023-05014.15
2023-06011.09
2023-07016.98
2023-08017.51
2023-09019.11
2023-10012.99
2023-11016.58
2023-12017.07
2024-01017.04
2024-02014.58
2024-03016.93
2024-04011.31
2024-05013.85
2024-06011.06
2024-07013.94
2024-08014.1
2024-09015.69
2024-10020.25
2024-11015.41
2024-12013.05
2025-01016.82
2025-02013.36
2025-03016.84
2025-04011.55
2025-05012.21
2025-06011.17
2025-07012.66
2025-08010.28
2025-0909.03
2025-10014.4
2025-11010.35
2025-12011.52
2026-01010.65
2026-02012.28
2026-03012.78
2026-04019.65
2026-05014.89
2026-06013.13
This device (reports/month)Average device in DQA, DRT, DSA, DSI, DSK, DXN, FLL, MHX (reports/device/month)

Regulatory clearances

  • K123048 SESE 2013-01-11 (k number procode)

Predicate lineage

K123048 — cited as predicate by K172966

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

Manufacturer compliance record — ADVANCED INSTRUMENTATIONS, INC.

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