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APEX®

Model 2112625 · B. BRAUN MEDICAL INC. · DI 04046955746804

KPE — Container, I.V. · Class II · 21 CFR 880.5025

UDILibrary device dossier · generated 2026-09-06 · 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.

24682019-01: 0 reports for this device; peer average 1.4/device2019-03: 0 reports for this device; peer average 4/device2019-04: 0 reports for this device; peer average 1.25/device2019-05: 0 reports for this device; peer average 1/device2019-06: 0 reports for this device; peer average 7.67/device2019-07: 0 reports for this device; peer average 2/device2019-08: 0 reports for this device; peer average 2/device2019-09: 0 reports for this device; peer average 2.17/device2019-10: 0 reports for this device; peer average 5/device2019-11: 0 reports for this device; peer average 2.5/device2019-12: 0 reports for this device; peer average 2.86/device2020-01: 0 reports for this device; peer average 2/device2020-02: 0 reports for this device; peer average 2/device2020-03: 0 reports for this device; peer average 2.43/device2020-04: 0 reports for this device; peer average 2.13/device2020-05: 0 reports for this device; peer average 1/device2020-06: 0 reports for this device; peer average 1/device2020-07: 0 reports for this device; peer average 1.25/device2020-08: 0 reports for this device; peer average 1/device2020-09: 0 reports for this device; peer average 1.25/device2020-10: 0 reports for this device; peer average 1.4/device2020-11: 0 reports for this device; peer average 1.67/device2020-12: 0 reports for this device; peer average 2/device2021-01: 0 reports for this device; peer average 1/device2021-02: 0 reports for this device; peer average 1.67/device2021-03: 0 reports for this device; peer average 2/device2021-04: 0 reports for this device; peer average 2.2/device2021-05: 0 reports for this device; peer average 1.44/device2021-06: 0 reports for this device; peer average 1.7/device2021-07: 0 reports for this device; peer average 2.56/device2021-08: 0 reports for this device; peer average 1/device2021-09: 0 reports for this device; peer average 1.33/device2021-10: 0 reports for this device; peer average 1/device2021-11: 0 reports for this device; peer average 2.6/device2021-12: 0 reports for this device; peer average 1.33/device2022-01: 0 reports for this device; peer average 2/device2022-02: 0 reports for this device; peer average 1.67/device2022-03: 0 reports for this device; peer average 2.25/device2022-04: 0 reports for this device; peer average 2.67/device2022-05: 0 reports for this device; peer average 1.5/device2022-06: 0 reports for this device; peer average 2.43/device2022-07: 0 reports for this device; peer average 1.29/device2022-08: 0 reports for this device; peer average 1/device2022-09: 0 reports for this device; peer average 1.33/device2022-10: 0 reports for this device; peer average 1.4/device2022-11: 0 reports for this device; peer average 1/device2022-12: 0 reports for this device; peer average 1.33/device2023-01: 0 reports for this device; peer average 1/device2023-02: 0 reports for this device; peer average 2.25/device2023-03: 0 reports for this device; peer average 2.44/device2023-04: 0 reports for this device; peer average 1.67/device2023-05: 0 reports for this device; peer average 1/device2023-06: 0 reports for this device; peer average 1.25/device2023-07: 0 reports for this device; peer average 1.5/device2023-08: 0 reports for this device; peer average 1/device2023-09: 0 reports for this device; peer average 2.2/device2023-10: 0 reports for this device; peer average 1/device2023-11: 0 reports for this device; peer average 1.67/device2023-12: 0 reports for this device; peer average 1/device2024-01: 0 reports for this device; peer average 1.75/device2024-02: 0 reports for this device; peer average 1.6/device2024-03: 0 reports for this device; peer average 1.5/device2024-04: 0 reports for this device; peer average 2.11/device2024-05: 0 reports for this device; peer average 1/device2024-06: 0 reports for this device; peer average 6.5/device2024-07: 0 reports for this device; peer average 3.25/device2024-08: 0 reports for this device; peer average 7.5/device2024-09: 0 reports for this device; peer average 3.57/device2024-10: 0 reports for this device; peer average 7.8/device2024-11: 0 reports for this device; peer average 1.14/device2024-12: 0 reports for this device; peer average 2.33/device2025-01: 0 reports for this device; peer average 1.44/device2025-02: 0 reports for this device; peer average 1.67/device2025-03: 0 reports for this device; peer average 7.14/device2025-04: 0 reports for this device; peer average 1.6/device2025-05: 0 reports for this device; peer average 1.13/device2025-06: 0 reports for this device; peer average 1.57/device2025-07: 0 reports for this device; peer average 1/device2025-08: 0 reports for this device; peer average 1.71/device2025-09: 0 reports for this device; peer average 1.67/device2025-10: 0 reports for this device; peer average 1/device2025-11: 0 reports for this device; peer average 3.4/device2025-12: 0 reports for this device; peer average 2.11/device2026-01: 0 reports for this device; peer average 2.17/device2026-02: 0 reports for this device; peer average 3.6/device2026-03: 0 reports for this device; peer average 2.22/device2026-04: 0 reports for this device; peer average 3.36/device2026-05: 0 reports for this device; peer average 1.71/device2026-06: 0 reports for this device; peer average 1.17/device0103040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.4
2019-0304
2019-0401.25
2019-0501
2019-0607.67
2019-0702
2019-0802
2019-0902.17
2019-1005
2019-1102.5
2019-1202.86
2020-0102
2020-0202
2020-0302.43
2020-0402.13
2020-0501
2020-0601
2020-0701.25
2020-0801
2020-0901.25
2020-1001.4
2020-1101.67
2020-1202
2021-0101
2021-0201.67
2021-0302
2021-0402.2
2021-0501.44
2021-0601.7
2021-0702.56
2021-0801
2021-0901.33
2021-1001
2021-1102.6
2021-1201.33
2022-0102
2022-0201.67
2022-0302.25
2022-0402.67
2022-0501.5
2022-0602.43
2022-0701.29
2022-0801
2022-0901.33
2022-1001.4
2022-1101
2022-1201.33
2023-0101
2023-0202.25
2023-0302.44
2023-0401.67
2023-0501
2023-0601.25
2023-0701.5
2023-0801
2023-0902.2
2023-1001
2023-1101.67
2023-1201
2024-0101.75
2024-0201.6
2024-0301.5
2024-0402.11
2024-0501
2024-0606.5
2024-0703.25
2024-0807.5
2024-0903.57
2024-1007.8
2024-1101.14
2024-1202.33
2025-0101.44
2025-0201.67
2025-0307.14
2025-0401.6
2025-0501.13
2025-0601.57
2025-0701
2025-0801.71
2025-0901.67
2025-1001
2025-1103.4
2025-1202.11
2026-0102.17
2026-0203.6
2026-0302.22
2026-0403.36
2026-0501.71
2026-0601.17
This device (reports/month)Average device in KPE (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — B. BRAUN MEDICAL INC.

  • NAI 2024-09-20 B. BRAUN DOMINICAN REPUBLIC INC. · 0 citations
  • NAI 2023-10-13 B. Braun US Pharmaceutical Manufacturing, LLC · 0 citations
  • NAI 2018-06-01 B. Braun Medical, Inc. · 0 citations
  • NAI 2018-06-01 B. Braun Medical, Inc. · 0 citations
  • NAI 2018-02-22 B. BRAUN DOMINICAN REPUBLIC INC. · 0 citations
  • VAI 2016-08-26 B. Braun Medical, Inc. · 2 citations
  • VAI 2016-08-26 B. Braun Medical, Inc. · 2 citations
  • NAI 2014-06-03 B. BRAUN MEDICAL AG · 0 citations
  • NAI 2013-01-10 B. BRAUN DOMINICAN REPUBLIC INC. · 0 citations
  • VAI 2012-12-13 B. Braun Medical, Inc. · 0 citations
  • VAI 2012-12-13 B. Braun Medical, Inc. · 0 citations
  • OAI 2012-08-16 B Braun Medical, Inc. · 6 citations
  • NAI 2011-03-21 B. Braun US Pharmaceutical Manufacturing, LLC · 0 citations
  • OAI 2010-10-08 B Braun Medical, Inc. · 5 citations