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Australian, Rapid Infuser, 230 V, 750ml/min

Model 903-00001A-AUS · BELMONT INSTRUMENT CORPORATION · DI 00896128002602

FRN — Pump, Infusion · Class II · 21 CFR 880.5725

LGZ — Warmer, Thermal, Infusion Fluid · Class II · 21 CFR 880.5725

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.

6741347202126952019-01: 0 reports for this device; peer average 10.56/device2019-02: 0 reports for this device; peer average 12.69/device2019-03: 0 reports for this device; peer average 11.63/device2019-04: 0 reports for this device; peer average 12.46/device2019-05: 0 reports for this device; peer average 12.27/device2019-06: 0 reports for this device; peer average 10.34/device2019-07: 0 reports for this device; peer average 11.67/device2019-08: 0 reports for this device; peer average 16.27/device2019-09: 0 reports for this device; peer average 12.2/device2019-10: 0 reports for this device; peer average 13.33/device2019-11: 0 reports for this device; peer average 16.63/device2019-12: 0 reports for this device; peer average 20.13/device2020-01: 0 reports for this device; peer average 14.15/device2020-02: 0 reports for this device; peer average 18.53/device2020-03: 0 reports for this device; peer average 17.04/device2020-04: 0 reports for this device; peer average 19.1/device2020-05: 0 reports for this device; peer average 30.98/device2020-06: 0 reports for this device; peer average 17.15/device2020-07: 0 reports for this device; peer average 24.74/device2020-08: 0 reports for this device; peer average 28.38/device2020-09: 0 reports for this device; peer average 74.85/device2020-10: 0 reports for this device; peer average 99.6/device2020-11: 0 reports for this device; peer average 192.07/device2020-12: 0 reports for this device; peer average 385.31/device2021-01: 0 reports for this device; peer average 264.09/device2021-02: 0 reports for this device; peer average 106.71/device2021-03: 0 reports for this device; peer average 77.38/device2021-04: 0 reports for this device; peer average 78.29/device2021-05: 0 reports for this device; peer average 72.41/device2021-06: 0 reports for this device; peer average 74.45/device2021-07: 0 reports for this device; peer average 89.1/device2021-08: 0 reports for this device; peer average 111.07/device2021-09: 0 reports for this device; peer average 151.73/device2021-10: 0 reports for this device; peer average 318.48/device2021-11: 0 reports for this device; peer average 385.2/device2021-12: 0 reports for this device; peer average 1212.16/device2022-01: 0 reports for this device; peer average 2694.92/device2022-02: 0 reports for this device; peer average 1413.28/device2022-03: 0 reports for this device; peer average 2239.43/device2022-04: 0 reports for this device; peer average 2411.59/device2022-05: 0 reports for this device; peer average 1936.71/device2022-06: 0 reports for this device; peer average 1803.15/device2022-07: 0 reports for this device; peer average 888.18/device2022-08: 0 reports for this device; peer average 227.64/device2022-09: 0 reports for this device; peer average 287.35/device2022-10: 0 reports for this device; peer average 256.49/device2022-11: 0 reports for this device; peer average 245.91/device2022-12: 0 reports for this device; peer average 228.98/device2023-01: 0 reports for this device; peer average 127.34/device2023-02: 0 reports for this device; peer average 255.75/device2023-03: 0 reports for this device; peer average 305.05/device2023-04: 0 reports for this device; peer average 263.63/device2023-05: 0 reports for this device; peer average 240.84/device2023-06: 0 reports for this device; peer average 298.8/device2023-07: 0 reports for this device; peer average 281.34/device2023-08: 0 reports for this device; peer average 268.34/device2023-09: 0 reports for this device; peer average 219.98/device2023-10: 0 reports for this device; peer average 129.77/device2023-11: 0 reports for this device; peer average 130.95/device2023-12: 0 reports for this device; peer average 63.55/device2024-01: 0 reports for this device; peer average 67.35/device2024-02: 0 reports for this device; peer average 101.17/device2024-03: 0 reports for this device; peer average 71.21/device2024-04: 0 reports for this device; peer average 76.75/device2024-05: 0 reports for this device; peer average 46.49/device2024-06: 0 reports for this device; peer average 50.21/device2024-07: 0 reports for this device; peer average 45.53/device2024-08: 0 reports for this device; peer average 41.36/device2024-09: 0 reports for this device; peer average 48.22/device2024-10: 0 reports for this device; peer average 50.88/device2024-11: 0 reports for this device; peer average 57.8/device2024-12: 0 reports for this device; peer average 53.16/device2025-01: 0 reports for this device; peer average 64.36/device2025-02: 0 reports for this device; peer average 57.67/device2025-03: 0 reports for this device; peer average 83.62/device2025-04: 0 reports for this device; peer average 71.4/device2025-05: 0 reports for this device; peer average 81.16/device2025-06: 0 reports for this device; peer average 87.33/device2025-07: 0 reports for this device; peer average 119.88/device2025-08: 0 reports for this device; peer average 83.67/device2025-09: 0 reports for this device; peer average 81.89/device2025-10: 0 reports for this device; peer average 93.65/device2025-11: 0 reports for this device; peer average 83/device2025-12: 0 reports for this device; peer average 88.56/device2026-01: 0 reports for this device; peer average 74.52/device2026-02: 0 reports for this device; peer average 76.73/device2026-03: 0 reports for this device; peer average 87.13/device2026-04: 0 reports for this device; peer average 143.63/device2026-05: 0 reports for this device; peer average 327.5/device2026-06: 0 reports for this device; peer average 351.16/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-01010.56
2019-02012.69
2019-03011.63
2019-04012.46
2019-05012.27
2019-06010.34
2019-07011.67
2019-08016.27
2019-09012.2
2019-10013.33
2019-11016.63
2019-12020.13
2020-01014.15
2020-02018.53
2020-03017.04
2020-04019.1
2020-05030.98
2020-06017.15
2020-07024.74
2020-08028.38
2020-09074.85
2020-10099.6
2020-110192.07
2020-120385.31
2021-010264.09
2021-020106.71
2021-03077.38
2021-04078.29
2021-05072.41
2021-06074.45
2021-07089.1
2021-080111.07
2021-090151.73
2021-100318.48
2021-110385.2
2021-1201212.16
2022-0102694.92
2022-0201413.28
2022-0302239.43
2022-0402411.59
2022-0501936.71
2022-0601803.15
2022-070888.18
2022-080227.64
2022-090287.35
2022-100256.49
2022-110245.91
2022-120228.98
2023-010127.34
2023-020255.75
2023-030305.05
2023-040263.63
2023-050240.84
2023-060298.8
2023-070281.34
2023-080268.34
2023-090219.98
2023-100129.77
2023-110130.95
2023-12063.55
2024-01067.35
2024-020101.17
2024-03071.21
2024-04076.75
2024-05046.49
2024-06050.21
2024-07045.53
2024-08041.36
2024-09048.22
2024-10050.88
2024-11057.8
2024-12053.16
2025-01064.36
2025-02057.67
2025-03083.62
2025-04071.4
2025-05081.16
2025-06087.33
2025-070119.88
2025-08083.67
2025-09081.89
2025-10093.65
2025-11083
2025-12088.56
2026-01074.52
2026-02076.73
2026-03087.13
2026-040143.63
2026-050327.5
2026-060351.16
This device (reports/month)Average device in FRN, LGZ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K091855 — cited as predicate by K141654

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

Manufacturer compliance record — BELMONT INSTRUMENT CORPORATION

  • Warning Letter 2012-05-07 Belmont Instrument LLC
  • Warning Letter 2012-05-07 Belmont Instrument LLC
  • VAI 2013-06-21 Belmont Instrument LLC · 2 citations
  • VAI 2013-06-21 Belmont Instrument LLC · 2 citations
  • VAI 2011-04-27 Belmont Instrument LLC · 3 citations
  • VAI 2011-04-27 Belmont Instrument LLC · 3 citations