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ADVANCED PATIENT MONITOR
Model PM-2000XL PRO · ADVANCED INSTRUMENTATIONS, INC. · DI B510PM2000XLPRO1
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
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 2026-09-12 · 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.
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
9.03
2019-02
0
7.26
2019-03
0
7.06
2019-04
0
6.59
2019-05
0
5.91
2019-06
0
5.22
2019-07
0
5.95
2019-08
0
6.66
2019-09
0
7.53
2019-10
0
7.32
2019-11
0
7.45
2019-12
0
6.87
2020-01
0
5.96
2020-02
0
6.43
2020-03
0
6.84
2020-04
0
9.01
2020-05
0
5.97
2020-06
0
6.38
2020-07
0
5.63
2020-08
0
6.89
2020-09
0
8.31
2020-10
0
7.87
2020-11
0
14.65
2020-12
0
19.95
2021-01
0
15.53
2021-02
0
8.84
2021-03
0
11.4
2021-04
0
9.7
2021-05
0
7.85
2021-06
0
9.82
2021-07
0
9.38
2021-08
0
10
2021-09
0
8
2021-10
0
9.12
2021-11
0
10.02
2021-12
0
10.42
2022-01
0
8.64
2022-02
0
9.09
2022-03
0
10.97
2022-04
0
8.79
2022-05
0
11.69
2022-06
0
7.51
2022-07
0
6.86
2022-08
0
8.57
2022-09
0
8.84
2022-10
0
10.32
2022-11
0
8.31
2022-12
0
9.44
2023-01
0
7.46
2023-02
0
13.27
2023-03
0
14.98
2023-04
0
14.47
2023-05
0
14.63
2023-06
0
11.55
2023-07
0
17.08
2023-08
0
17.12
2023-09
0
19.22
2023-10
0
13.03
2023-11
0
16.08
2023-12
0
16.79
2024-01
0
15.83
2024-02
0
14.99
2024-03
0
17.47
2024-04
0
10.37
2024-05
0
11.74
2024-06
0
10.27
2024-07
0
14.13
2024-08
0
14.06
2024-09
0
16.03
2024-10
0
18.82
2024-11
0
14.74
2024-12
0
13.5
2025-01
0
15.54
2025-02
0
12.56
2025-03
0
16.11
2025-04
0
11.79
2025-05
0
11.41
2025-06
0
9.96
2025-07
0
13.01
2025-08
0
8.78
2025-09
0
8.86
2025-10
0
13.57
2025-11
0
9.83
2025-12
0
11.45
2026-01
0
10.2
2026-02
0
12.51
2026-03
0
11.86
2026-04
0
18.45
2026-05
0
15.53
2026-06
0
14.78
This device (reports/month)Average device in CBQ, CBR, CBS, CCK, CCL, DQA, DRT, DSA, DSF, DSK, DXN, FLL, MHX, MLD (reports/device/month)
Regulatory clearances
K120631 SESE 2012-05-25 (k number procode)
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