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AIV

Model BX10468 · AMERICAN IV PRODUCTS, INC. · DI M745BX10468

FRN — Pump, Infusion · 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.

7331467220029342019-01: 0 reports for this device; peer average 11.56/device2019-02: 0 reports for this device; peer average 13.35/device2019-03: 0 reports for this device; peer average 14.04/device2019-04: 0 reports for this device; peer average 14.67/device2019-05: 0 reports for this device; peer average 13.73/device2019-06: 0 reports for this device; peer average 11.2/device2019-07: 0 reports for this device; peer average 12.88/device2019-08: 0 reports for this device; peer average 17.93/device2019-09: 0 reports for this device; peer average 13.93/device2019-10: 0 reports for this device; peer average 15.12/device2019-11: 0 reports for this device; peer average 18.44/device2019-12: 0 reports for this device; peer average 25.68/device2020-01: 0 reports for this device; peer average 15.21/device2020-02: 0 reports for this device; peer average 21.44/device2020-03: 0 reports for this device; peer average 19.57/device2020-04: 0 reports for this device; peer average 21.08/device2020-05: 0 reports for this device; peer average 34.71/device2020-06: 0 reports for this device; peer average 19.38/device2020-07: 0 reports for this device; peer average 28.1/device2020-08: 0 reports for this device; peer average 33.51/device2020-09: 0 reports for this device; peer average 92.58/device2020-10: 0 reports for this device; peer average 113.47/device2020-11: 0 reports for this device; peer average 241.82/device2020-12: 0 reports for this device; peer average 493.74/device2021-01: 0 reports for this device; peer average 312.78/device2021-02: 0 reports for this device; peer average 124.55/device2021-03: 0 reports for this device; peer average 88.37/device2021-04: 0 reports for this device; peer average 90.87/device2021-05: 0 reports for this device; peer average 82.05/device2021-06: 0 reports for this device; peer average 85.82/device2021-07: 0 reports for this device; peer average 107.95/device2021-08: 0 reports for this device; peer average 138.66/device2021-09: 0 reports for this device; peer average 168.13/device2021-10: 0 reports for this device; peer average 358.71/device2021-11: 0 reports for this device; peer average 423.55/device2021-12: 0 reports for this device; peer average 1317.75/device2022-01: 0 reports for this device; peer average 2933.87/device2022-02: 0 reports for this device; peer average 1625.53/device2022-03: 0 reports for this device; peer average 2497.38/device2022-04: 0 reports for this device; peer average 2604.18/device2022-05: 0 reports for this device; peer average 2120.89/device2022-06: 0 reports for this device; peer average 2109.64/device2022-07: 0 reports for this device; peer average 967.29/device2022-08: 0 reports for this device; peer average 256.24/device2022-09: 0 reports for this device; peer average 313.05/device2022-10: 0 reports for this device; peer average 296.73/device2022-11: 0 reports for this device; peer average 274.1/device2022-12: 0 reports for this device; peer average 255.15/device2023-01: 0 reports for this device; peer average 133.96/device2023-02: 0 reports for this device; peer average 286.77/device2023-03: 0 reports for this device; peer average 331.09/device2023-04: 0 reports for this device; peer average 285.47/device2023-05: 0 reports for this device; peer average 260.64/device2023-06: 0 reports for this device; peer average 331.33/device2023-07: 0 reports for this device; peer average 330.53/device2023-08: 0 reports for this device; peer average 314.7/device2023-09: 0 reports for this device; peer average 265.98/device2023-10: 0 reports for this device; peer average 150.04/device2023-11: 0 reports for this device; peer average 141.94/device2023-12: 0 reports for this device; peer average 71.12/device2024-01: 0 reports for this device; peer average 71.6/device2024-02: 0 reports for this device; peer average 108.97/device2024-03: 0 reports for this device; peer average 78.95/device2024-04: 0 reports for this device; peer average 82.21/device2024-05: 0 reports for this device; peer average 48.37/device2024-06: 0 reports for this device; peer average 55.64/device2024-07: 0 reports for this device; peer average 51.72/device2024-08: 0 reports for this device; peer average 44.13/device2024-09: 0 reports for this device; peer average 51.99/device2024-10: 0 reports for this device; peer average 55.6/device2024-11: 0 reports for this device; peer average 61.71/device2024-12: 0 reports for this device; peer average 57.79/device2025-01: 0 reports for this device; peer average 70.59/device2025-02: 0 reports for this device; peer average 62.26/device2025-03: 0 reports for this device; peer average 93.84/device2025-04: 0 reports for this device; peer average 77.56/device2025-05: 0 reports for this device; peer average 91.64/device2025-06: 0 reports for this device; peer average 96.63/device2025-07: 0 reports for this device; peer average 127.32/device2025-08: 0 reports for this device; peer average 91.72/device2025-09: 0 reports for this device; peer average 89.34/device2025-10: 0 reports for this device; peer average 98.39/device2025-11: 0 reports for this device; peer average 90.06/device2025-12: 0 reports for this device; peer average 95.49/device2026-01: 0 reports for this device; peer average 81.49/device2026-02: 0 reports for this device; peer average 86.01/device2026-03: 0 reports for this device; peer average 95.82/device2026-04: 0 reports for this device; peer average 157.58/device2026-05: 0 reports for this device; peer average 361.57/device2026-06: 0 reports for this device; peer average 366.13/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-01011.56
2019-02013.35
2019-03014.04
2019-04014.67
2019-05013.73
2019-06011.2
2019-07012.88
2019-08017.93
2019-09013.93
2019-10015.12
2019-11018.44
2019-12025.68
2020-01015.21
2020-02021.44
2020-03019.57
2020-04021.08
2020-05034.71
2020-06019.38
2020-07028.1
2020-08033.51
2020-09092.58
2020-100113.47
2020-110241.82
2020-120493.74
2021-010312.78
2021-020124.55
2021-03088.37
2021-04090.87
2021-05082.05
2021-06085.82
2021-070107.95
2021-080138.66
2021-090168.13
2021-100358.71
2021-110423.55
2021-1201317.75
2022-0102933.87
2022-0201625.53
2022-0302497.38
2022-0402604.18
2022-0502120.89
2022-0602109.64
2022-070967.29
2022-080256.24
2022-090313.05
2022-100296.73
2022-110274.1
2022-120255.15
2023-010133.96
2023-020286.77
2023-030331.09
2023-040285.47
2023-050260.64
2023-060331.33
2023-070330.53
2023-080314.7
2023-090265.98
2023-100150.04
2023-110141.94
2023-12071.12
2024-01071.6
2024-020108.97
2024-03078.95
2024-04082.21
2024-05048.37
2024-06055.64
2024-07051.72
2024-08044.13
2024-09051.99
2024-10055.6
2024-11061.71
2024-12057.79
2025-01070.59
2025-02062.26
2025-03093.84
2025-04077.56
2025-05091.64
2025-06096.63
2025-070127.32
2025-08091.72
2025-09089.34
2025-10098.39
2025-11090.06
2025-12095.49
2026-01081.49
2026-02086.01
2026-03095.82
2026-040157.58
2026-050361.57
2026-060366.13
This device (reports/month)Average device in FRN (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — AMERICAN IV PRODUCTS, INC.

  • VAI 2024-08-12 American IV Products, Inc. · 3 citations
  • VAI 2018-09-12 American IV Products, Inc. · 4 citations
  • VAI 2016-10-19 American IV Products, Inc. · 3 citations
  • NAI 2014-04-09 American IV Products, Inc. · 0 citations
  • NAI 2011-07-27 American IV Products, Inc. · 0 citations
  • VAI 2010-07-21 American IV Products, Inc. · 4 citations