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Benchmark

Model BMK6F95BER120-A · PENUMBRA, INC. · DI 00815948025189

DQY — Catheter, Percutaneous · Class II · 21 CFR 870.1250

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 (11)

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.

Injury: 6 · Malfunction: 5

12342019-01: 0 reports for this device; peer average 2.61/device2019-02: 0 reports for this device; peer average 1.91/device2019-03: 0 reports for this device; peer average 1.82/device2019-04: 0 reports for this device; peer average 2.36/device2019-05: 0 reports for this device; peer average 1.75/device2019-06: 0 reports for this device; peer average 1.88/device2019-07: 0 reports for this device; peer average 2.51/device2019-08: 0 reports for this device; peer average 1.98/device2019-09: 0 reports for this device; peer average 1.7/device2019-10: 0 reports for this device; peer average 2.7/device2019-11: 0 reports for this device; peer average 1.95/device2019-12: 0 reports for this device; peer average 2.02/device2020-01: 0 reports for this device; peer average 2.84/device2020-02: 0 reports for this device; peer average 2.03/device2020-03: 0 reports for this device; peer average 2.19/device2020-04: 0 reports for this device; peer average 2.62/device2020-05: 0 reports for this device; peer average 2/device2020-06: 0 reports for this device; peer average 2.3/device2020-07: 0 reports for this device; peer average 3.16/device2020-08: 0 reports for this device; peer average 2.25/device2020-09: 0 reports for this device; peer average 2.27/device2020-10: 0 reports for this device; peer average 3.12/device2020-11: 0 reports for this device; peer average 2.26/device2020-12: 0 reports for this device; peer average 2.59/device2021-01: 0 reports for this device; peer average 2.54/device2021-02: 0 reports for this device; peer average 2.54/device2021-03: 0 reports for this device; peer average 2.38/device2021-04: 0 reports for this device; peer average 2.24/device2021-05: 0 reports for this device; peer average 2.74/device2021-06: 0 reports for this device; peer average 2.46/device2021-07: 0 reports for this device; peer average 2.21/device2021-08: 0 reports for this device; peer average 2.49/device2021-09: 0 reports for this device; peer average 2.25/device2021-10: 0 reports for this device; peer average 2.36/device2021-11: 0 reports for this device; peer average 2.08/device2021-12: 0 reports for this device; peer average 2.26/device2022-01: 0 reports for this device; peer average 2.18/device2022-02: 0 reports for this device; peer average 2.17/device2022-03: 0 reports for this device; peer average 1.97/device2022-04: 0 reports for this device; peer average 2.25/device2022-05: 0 reports for this device; peer average 1.86/device2022-06: 0 reports for this device; peer average 2.22/device2022-07: 0 reports for this device; peer average 2.06/device2022-08: 0 reports for this device; peer average 2.37/device2022-09: 0 reports for this device; peer average 2.18/device2022-10: 0 reports for this device; peer average 2.2/device2022-11: 0 reports for this device; peer average 2.06/device2022-12: 0 reports for this device; peer average 1.92/device2023-01: 0 reports for this device; peer average 1.8/device2023-02: 0 reports for this device; peer average 1.96/device2023-03: 0 reports for this device; peer average 2.01/device2023-04: 0 reports for this device; peer average 2.13/device2023-05: 0 reports for this device; peer average 1.85/device2023-06: 0 reports for this device; peer average 2.11/device2023-07: 0 reports for this device; peer average 2.05/device2023-08: 0 reports for this device; peer average 1.85/device2023-09: 1 reports for this device; peer average 1.92/device2023-10: 0 reports for this device; peer average 2.21/device2023-11: 0 reports for this device; peer average 2.39/device2023-12: 0 reports for this device; peer average 2.42/device2024-01: 2 reports for this device; peer average 1.77/device2024-02: 0 reports for this device; peer average 1.96/device2024-03: 0 reports for this device; peer average 1.83/device2024-04: 0 reports for this device; peer average 1.92/device2024-05: 0 reports for this device; peer average 1.94/device2024-06: 0 reports for this device; peer average 2.12/device2024-07: 0 reports for this device; peer average 1.99/device2024-08: 0 reports for this device; peer average 1.97/device2024-09: 0 reports for this device; peer average 2.07/device2024-10: 1 reports for this device; peer average 2.28/device2024-11: 0 reports for this device; peer average 2.41/device2024-12: 0 reports for this device; peer average 2.97/device2025-01: 2 reports for this device; peer average 2.91/device2025-02: 1 reports for this device; peer average 2.87/device2025-03: 0 reports for this device; peer average 2.68/device2025-04: 0 reports for this device; peer average 2.49/device2025-05: 0 reports for this device; peer average 2.66/device2025-06: 0 reports for this device; peer average 3.23/device2025-07: 0 reports for this device; peer average 3.2/device2025-08: 0 reports for this device; peer average 2.73/device2025-09: 0 reports for this device; peer average 2.88/device2025-10: 0 reports for this device; peer average 3.24/device2025-11: 1 reports for this device; peer average 3.19/device2025-12: 1 reports for this device; peer average 3.84/device2026-01: 0 reports for this device; peer average 3.49/device2026-02: 1 reports for this device; peer average 3.34/device2026-03: 0 reports for this device; peer average 3.29/device2026-04: 1 reports for this device; peer average 3.06/device2026-05: 0 reports for this device; peer average 3.41/device2026-06: 0 reports for this device; peer average 3.38/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.61
2019-0201.91
2019-0301.82
2019-0402.36
2019-0501.75
2019-0601.88
2019-0702.51
2019-0801.98
2019-0901.7
2019-1002.7
2019-1101.95
2019-1202.02
2020-0102.84
2020-0202.03
2020-0302.19
2020-0402.62
2020-0502
2020-0602.3
2020-0703.16
2020-0802.25
2020-0902.27
2020-1003.12
2020-1102.26
2020-1202.59
2021-0102.54
2021-0202.54
2021-0302.38
2021-0402.24
2021-0502.74
2021-0602.46
2021-0702.21
2021-0802.49
2021-0902.25
2021-1002.36
2021-1102.08
2021-1202.26
2022-0102.18
2022-0202.17
2022-0301.97
2022-0402.25
2022-0501.86
2022-0602.22
2022-0702.06
2022-0802.37
2022-0902.18
2022-1002.2
2022-1102.06
2022-1201.92
2023-0101.8
2023-0201.96
2023-0302.01
2023-0402.13
2023-0501.85
2023-0602.11
2023-0702.05
2023-0801.85
2023-0911.92
2023-1002.21
2023-1102.39
2023-1202.42
2024-0121.77
2024-0201.96
2024-0301.83
2024-0401.92
2024-0501.94
2024-0602.12
2024-0701.99
2024-0801.97
2024-0902.07
2024-1012.28
2024-1102.41
2024-1202.97
2025-0122.91
2025-0212.87
2025-0302.68
2025-0402.49
2025-0502.66
2025-0603.23
2025-0703.2
2025-0802.73
2025-0902.88
2025-1003.24
2025-1113.19
2025-1213.84
2026-0103.49
2026-0213.34
2026-0303.29
2026-0413.06
2026-0503.41
2026-0603.38
This device (reports/month)Average device in DQY (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K142321 — cites (transitively): K082290 (d1), K083125 (d1) — cited as predicate by K181000, K200417, K212838, K233201

K212838 — cites (transitively): K083125 (d1), K142321 (d1), K082290 (d2) — cited as predicate by K221822, K230322, K230775, K240746, K243593, K253032, K253975

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

Manufacturer compliance record — PENUMBRA, INC.

  • Warning Letter 2009-12-31 Penumbra Inc.
  • Warning Letter 2009-12-31 Penumbra Inc.
  • NAI 2021-06-21 Penumbra Inc. · 0 citations
  • NAI 2021-06-21 Penumbra Inc. · 0 citations
  • NAI 2017-02-13 Penumbra Inc. · 0 citations
  • NAI 2017-02-13 Penumbra Inc. · 0 citations
  • VAI 2016-02-23 Penumbra Inc. · 0 citations
  • VAI 2016-02-23 Penumbra Inc. · 0 citations
  • VAI 2015-08-04 Penumbra Inc. · 1 citations
  • VAI 2015-08-04 Penumbra Inc. · 1 citations
  • VAI 2015-07-15 Penumbra Inc. · 1 citations
  • VAI 2015-07-15 Penumbra Inc. · 1 citations
  • NAI 2014-04-30 Penumbra Inc. · 0 citations
  • NAI 2014-04-30 Penumbra Inc. · 0 citations
  • NAI 2012-02-27 Penumbra Inc. · 0 citations
  • NAI 2012-02-27 Penumbra Inc. · 0 citations
  • VAI 2010-08-24 Penumbra Inc. · 1 citations
  • VAI 2010-08-24 Penumbra Inc. · 1 citations