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ADVANCED PATIENT MONITOR Model PM-Max15 · ADVANCED INSTRUMENTATIONS, INC. · DI B510PMMAX15
CBQ — Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) · Class II · 21 CFR 868.1500
CBR — Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) · Class II · 21 CFR 868.1700
CBS — Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) · Class II · 21 CFR 868.1620
CCK — Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase · Class II · 21 CFR 868.1400
CCL — Analyzer, Gas, Oxygen, Gaseous-Phase · Class II · 21 CFR 868.1720
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
DSF — Recorder, Paper Chart · Class I · 21 CFR 870.2810
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
MLD — Monitor, St Segment With Alarm · Class II · 21 CFR 870.1025
UDILibrary device dossier · generated 2026-09-14 · 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.
5 10 15 20 2019-01: 0 reports for this device; peer average 12.02/device 2019-02: 0 reports for this device; peer average 9.83/device 2019-03: 0 reports for this device; peer average 11.51/device 2019-04: 0 reports for this device; peer average 9.53/device 2019-05: 0 reports for this device; peer average 8.55/device 2019-06: 0 reports for this device; peer average 7.82/device 2019-07: 0 reports for this device; peer average 9.62/device 2019-08: 0 reports for this device; peer average 8.65/device 2019-09: 0 reports for this device; peer average 11.19/device 2019-10: 0 reports for this device; peer average 10.03/device 2019-11: 0 reports for this device; peer average 10.95/device 2019-12: 0 reports for this device; peer average 10.18/device 2020-01: 0 reports for this device; peer average 9.32/device 2020-02: 0 reports for this device; peer average 9.67/device 2020-03: 0 reports for this device; peer average 10.37/device 2020-04: 0 reports for this device; peer average 10.22/device 2020-05: 0 reports for this device; peer average 7.59/device 2020-06: 0 reports for this device; peer average 8.42/device 2020-07: 0 reports for this device; peer average 7.64/device 2020-08: 0 reports for this device; peer average 9.41/device 2020-09: 0 reports for this device; peer average 9.88/device 2020-10: 0 reports for this device; peer average 9.55/device 2020-11: 0 reports for this device; peer average 16.7/device 2020-12: 0 reports for this device; peer average 19.63/device 2021-01: 0 reports for this device; peer average 14.9/device 2021-02: 0 reports for this device; peer average 9.97/device 2021-03: 0 reports for this device; peer average 12.6/device 2021-04: 0 reports for this device; peer average 11.5/device 2021-05: 0 reports for this device; peer average 9.19/device 2021-06: 0 reports for this device; peer average 10.89/device 2021-07: 0 reports for this device; peer average 10/device 2021-08: 0 reports for this device; peer average 10.42/device 2021-09: 0 reports for this device; peer average 9.46/device 2021-10: 0 reports for this device; peer average 9.16/device 2021-11: 0 reports for this device; peer average 10.45/device 2021-12: 0 reports for this device; peer average 10.53/device 2022-01: 0 reports for this device; peer average 9.64/device 2022-02: 0 reports for this device; peer average 9.57/device 2022-03: 0 reports for this device; peer average 11.19/device 2022-04: 0 reports for this device; peer average 9.86/device 2022-05: 0 reports for this device; peer average 11.87/device 2022-06: 0 reports for this device; peer average 7.92/device 2022-07: 0 reports for this device; peer average 7.24/device 2022-08: 0 reports for this device; peer average 9.05/device 2022-09: 0 reports for this device; peer average 9.37/device 2022-10: 0 reports for this device; peer average 11.55/device 2022-11: 0 reports for this device; peer average 8.81/device 2022-12: 0 reports for this device; peer average 10.01/device 2023-01: 0 reports for this device; peer average 7.91/device 2023-02: 0 reports for this device; peer average 13.5/device 2023-03: 0 reports for this device; peer average 15.33/device 2023-04: 0 reports for this device; peer average 13.93/device 2023-05: 0 reports for this device; peer average 14.98/device 2023-06: 0 reports for this device; peer average 11.74/device 2023-07: 0 reports for this device; peer average 16.82/device 2023-08: 0 reports for this device; peer average 17.24/device 2023-09: 0 reports for this device; peer average 18.53/device 2023-10: 0 reports for this device; peer average 13.02/device 2023-11: 0 reports for this device; peer average 16.24/device 2023-12: 0 reports for this device; peer average 15.95/device 2024-01: 0 reports for this device; peer average 15.91/device 2024-02: 0 reports for this device; peer average 14.85/device 2024-03: 0 reports for this device; peer average 16.69/device 2024-04: 0 reports for this device; peer average 10.54/device 2024-05: 0 reports for this device; peer average 12.87/device 2024-06: 0 reports for this device; peer average 10.82/device 2024-07: 0 reports for this device; peer average 13.57/device 2024-08: 0 reports for this device; peer average 13.87/device 2024-09: 0 reports for this device; peer average 15.34/device 2024-10: 0 reports for this device; peer average 19.15/device 2024-11: 0 reports for this device; peer average 14.56/device 2024-12: 0 reports for this device; peer average 13.1/device 2025-01: 0 reports for this device; peer average 15.6/device 2025-02: 0 reports for this device; peer average 12.33/device 2025-03: 0 reports for this device; peer average 16.08/device 2025-04: 0 reports for this device; peer average 11.29/device 2025-05: 0 reports for this device; peer average 11.92/device 2025-06: 0 reports for this device; peer average 10.35/device 2025-07: 0 reports for this device; peer average 13.31/device 2025-08: 0 reports for this device; peer average 9.91/device 2025-09: 0 reports for this device; peer average 8.82/device 2025-10: 0 reports for this device; peer average 13.61/device 2025-11: 0 reports for this device; peer average 10.4/device 2025-12: 0 reports for this device; peer average 11.63/device 2026-01: 0 reports for this device; peer average 10.63/device 2026-02: 0 reports for this device; peer average 12.41/device 2026-03: 0 reports for this device; peer average 12.25/device 2026-04: 0 reports for this device; peer average 18.66/device 2026-05: 0 reports for this device; peer average 15.48/device 2026-06: 0 reports for this device; peer average 14.94/device 01 02 03 04 05 06 07 08 09 10 11 12 01 02 03 04 05 06 07 08 09 10 11 12 01 02 03 04 05 06 07 08 09 10 11 12 01 02 03 04 05 06 07 08 09 10 11 12 01 02 03 04 05 06 07 08 09 10 11 12 01 02 03 04 05 06 07 08 09 10 11 12 01 02 03 04 05 06 07 08 09 10 11 12 01 02 03 04 05 06 Monthly adverse-event reports for this device versus the product-code average. Month This device (reports) Product-code average (reports per device) 2019-01 0 12.02 2019-02 0 9.83 2019-03 0 11.51 2019-04 0 9.53 2019-05 0 8.55 2019-06 0 7.82 2019-07 0 9.62 2019-08 0 8.65 2019-09 0 11.19 2019-10 0 10.03 2019-11 0 10.95 2019-12 0 10.18 2020-01 0 9.32 2020-02 0 9.67 2020-03 0 10.37 2020-04 0 10.22 2020-05 0 7.59 2020-06 0 8.42 2020-07 0 7.64 2020-08 0 9.41 2020-09 0 9.88 2020-10 0 9.55 2020-11 0 16.7 2020-12 0 19.63 2021-01 0 14.9 2021-02 0 9.97 2021-03 0 12.6 2021-04 0 11.5 2021-05 0 9.19 2021-06 0 10.89 2021-07 0 10 2021-08 0 10.42 2021-09 0 9.46 2021-10 0 9.16 2021-11 0 10.45 2021-12 0 10.53 2022-01 0 9.64 2022-02 0 9.57 2022-03 0 11.19 2022-04 0 9.86 2022-05 0 11.87 2022-06 0 7.92 2022-07 0 7.24 2022-08 0 9.05 2022-09 0 9.37 2022-10 0 11.55 2022-11 0 8.81 2022-12 0 10.01 2023-01 0 7.91 2023-02 0 13.5 2023-03 0 15.33 2023-04 0 13.93 2023-05 0 14.98 2023-06 0 11.74 2023-07 0 16.82 2023-08 0 17.24 2023-09 0 18.53 2023-10 0 13.02 2023-11 0 16.24 2023-12 0 15.95 2024-01 0 15.91 2024-02 0 14.85 2024-03 0 16.69 2024-04 0 10.54 2024-05 0 12.87 2024-06 0 10.82 2024-07 0 13.57 2024-08 0 13.87 2024-09 0 15.34 2024-10 0 19.15 2024-11 0 14.56 2024-12 0 13.1 2025-01 0 15.6 2025-02 0 12.33 2025-03 0 16.08 2025-04 0 11.29 2025-05 0 11.92 2025-06 0 10.35 2025-07 0 13.31 2025-08 0 9.91 2025-09 0 8.82 2025-10 0 13.61 2025-11 0 10.4 2025-12 0 11.63 2026-01 0 10.63 2026-02 0 12.41 2026-03 0 12.25 2026-04 0 18.66 2026-05 0 15.48 2026-06 0 14.94
This device (reports/month) Average device in CBQ, CBR, CBS, CCK, CCL, DQA, DRT, DSA, DSF, DSI, DSK, DXN, FLL, MHX, MLD (reports/device/month)Regulatory clearances None linked in the loaded window. Manufacturer compliance record — ADVANCED INSTRUMENTATIONS, INC. OAI 2025-04-17 Advanced Instrumentations, Inc. · 5 citations OAI 2025-04-17 Advanced Instrumentations, Inc. · 5 citations VAI 2024-02-26 Advanced Instrumentations, Inc. · 3 citations VAI 2024-02-26 Advanced Instrumentations, Inc. · 3 citations VAI 2023-03-10 Advanced Instrumentations, Inc. · 4 citations VAI 2023-03-10 Advanced Instrumentations, Inc. · 4 citations VAI 2020-01-15 Advanced Instrumentations, Inc. · 3 citations VAI 2020-01-15 Advanced Instrumentations, Inc. · 3 citations VAI 2013-06-14 Advanced Instrumentations, Inc. · 6 citations VAI 2013-06-14 Advanced Instrumentations, Inc. · 6 citations Latest source-reported record dates: openfda_recall 2026-08-18 · openfda_event 2026-06-30 · fda_inspections 2026-08-06 · gudid_daily 2026-09-12. Events are linked to this device by the methods shown per row ("link basis"); "clearance family" links cover the 510(k)/PMA family, not necessarily this exact model. Free data from udilibrary — verify against primary FDA sources before regulatory use.