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ACE

Model 5MAXACE068L127 · PENUMBRA, INC. · DI 00814548016528

NRY — Catheter, Thrombus Retriever · 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 (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.

13462019-01: 0 reports for this device; peer average 2.64/device2019-02: 0 reports for this device; peer average 3.27/device2019-03: 0 reports for this device; peer average 2.21/device2019-04: 0 reports for this device; peer average 2.4/device2019-05: 0 reports for this device; peer average 2.18/device2019-06: 0 reports for this device; peer average 3.28/device2019-07: 0 reports for this device; peer average 3.95/device2019-08: 0 reports for this device; peer average 3.9/device2019-09: 0 reports for this device; peer average 2.53/device2019-10: 0 reports for this device; peer average 3.61/device2019-11: 0 reports for this device; peer average 3.11/device2019-12: 0 reports for this device; peer average 3.55/device2020-01: 0 reports for this device; peer average 3.91/device2020-02: 0 reports for this device; peer average 5.88/device2020-03: 0 reports for this device; peer average 3.63/device2020-04: 0 reports for this device; peer average 3.42/device2020-05: 0 reports for this device; peer average 4.13/device2020-06: 0 reports for this device; peer average 3.5/device2020-07: 0 reports for this device; peer average 3.28/device2020-08: 0 reports for this device; peer average 3.71/device2020-09: 0 reports for this device; peer average 3.21/device2020-10: 0 reports for this device; peer average 3.89/device2020-11: 0 reports for this device; peer average 4.39/device2020-12: 0 reports for this device; peer average 4.48/device2021-01: 0 reports for this device; peer average 3.62/device2021-02: 0 reports for this device; peer average 3.65/device2021-03: 0 reports for this device; peer average 3/device2021-04: 0 reports for this device; peer average 3.29/device2021-05: 0 reports for this device; peer average 3.35/device2021-06: 0 reports for this device; peer average 2.53/device2021-07: 0 reports for this device; peer average 2.68/device2021-08: 0 reports for this device; peer average 3.19/device2021-09: 0 reports for this device; peer average 4/device2021-10: 0 reports for this device; peer average 4/device2021-11: 0 reports for this device; peer average 4.62/device2021-12: 0 reports for this device; peer average 4.36/device2022-01: 0 reports for this device; peer average 4.08/device2022-02: 0 reports for this device; peer average 5.7/device2022-03: 0 reports for this device; peer average 4.5/device2022-04: 0 reports for this device; peer average 2.69/device2022-05: 0 reports for this device; peer average 2.38/device2022-06: 0 reports for this device; peer average 3.81/device2022-07: 0 reports for this device; peer average 3.17/device2022-08: 0 reports for this device; peer average 1.84/device2022-09: 0 reports for this device; peer average 2.82/device2022-10: 0 reports for this device; peer average 3.67/device2022-11: 0 reports for this device; peer average 1.77/device2022-12: 0 reports for this device; peer average 3.07/device2023-01: 0 reports for this device; peer average 2.73/device2023-02: 0 reports for this device; peer average 2.82/device2023-03: 0 reports for this device; peer average 2.85/device2023-04: 0 reports for this device; peer average 2.62/device2023-05: 0 reports for this device; peer average 2.88/device2023-06: 0 reports for this device; peer average 3.52/device2023-07: 0 reports for this device; peer average 2.31/device2023-08: 0 reports for this device; peer average 3.3/device2023-09: 0 reports for this device; peer average 2.5/device2023-10: 0 reports for this device; peer average 3.17/device2023-11: 0 reports for this device; peer average 3.07/device2023-12: 0 reports for this device; peer average 2.79/device2024-01: 0 reports for this device; peer average 2.65/device2024-02: 0 reports for this device; peer average 3.08/device2024-03: 0 reports for this device; peer average 2.45/device2024-04: 0 reports for this device; peer average 3.24/device2024-05: 0 reports for this device; peer average 2.7/device2024-06: 0 reports for this device; peer average 1.73/device2024-07: 0 reports for this device; peer average 2.53/device2024-08: 0 reports for this device; peer average 3.2/device2024-09: 0 reports for this device; peer average 2.36/device2024-10: 0 reports for this device; peer average 2.81/device2024-11: 0 reports for this device; peer average 2.44/device2024-12: 0 reports for this device; peer average 2.55/device2025-01: 0 reports for this device; peer average 1.89/device2025-02: 0 reports for this device; peer average 2.82/device2025-03: 0 reports for this device; peer average 1.65/device2025-04: 0 reports for this device; peer average 3.24/device2025-05: 0 reports for this device; peer average 2/device2025-06: 0 reports for this device; peer average 2.68/device2025-07: 0 reports for this device; peer average 2.21/device2025-08: 0 reports for this device; peer average 1.5/device2025-09: 0 reports for this device; peer average 1.88/device2025-10: 0 reports for this device; peer average 2.43/device2025-11: 0 reports for this device; peer average 1.6/device2025-12: 0 reports for this device; peer average 2.35/device2026-01: 0 reports for this device; peer average 1.94/device2026-02: 0 reports for this device; peer average 2/device2026-03: 0 reports for this device; peer average 1.76/device2026-04: 0 reports for this device; peer average 4.18/device2026-05: 0 reports for this device; peer average 3.5/device2026-06: 0 reports for this device; peer average 2.58/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.64
2019-0203.27
2019-0302.21
2019-0402.4
2019-0502.18
2019-0603.28
2019-0703.95
2019-0803.9
2019-0902.53
2019-1003.61
2019-1103.11
2019-1203.55
2020-0103.91
2020-0205.88
2020-0303.63
2020-0403.42
2020-0504.13
2020-0603.5
2020-0703.28
2020-0803.71
2020-0903.21
2020-1003.89
2020-1104.39
2020-1204.48
2021-0103.62
2021-0203.65
2021-0303
2021-0403.29
2021-0503.35
2021-0602.53
2021-0702.68
2021-0803.19
2021-0904
2021-1004
2021-1104.62
2021-1204.36
2022-0104.08
2022-0205.7
2022-0304.5
2022-0402.69
2022-0502.38
2022-0603.81
2022-0703.17
2022-0801.84
2022-0902.82
2022-1003.67
2022-1101.77
2022-1203.07
2023-0102.73
2023-0202.82
2023-0302.85
2023-0402.62
2023-0502.88
2023-0603.52
2023-0702.31
2023-0803.3
2023-0902.5
2023-1003.17
2023-1103.07
2023-1202.79
2024-0102.65
2024-0203.08
2024-0302.45
2024-0403.24
2024-0502.7
2024-0601.73
2024-0702.53
2024-0803.2
2024-0902.36
2024-1002.81
2024-1102.44
2024-1202.55
2025-0101.89
2025-0202.82
2025-0301.65
2025-0403.24
2025-0502
2025-0602.68
2025-0702.21
2025-0801.5
2025-0901.88
2025-1002.43
2025-1101.6
2025-1202.35
2026-0101.94
2026-0202
2026-0301.76
2026-0404.18
2026-0503.5
2026-0602.58
This device (reports/month)Average device in NRY (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K142458 — cites (transitively): K072718 (d1), K090752 (d1), K100769 (d1), K113163 (d1), K133317 (d1) — cited as predicate by K151623, K152541, K160449, K211697, K223545

K161640 — cites (transitively): K160449 (d1), K051758 (d2), K072718 (d2), K090752 (d2), K100769 (d2), K113163 (d2), K122756 (d2), K133317 (d2), K142458 (d2), K151623 (d2), K152541 (d2) — cited as predicate by K162901, K173761, K183464, K190010, K203440, K211411, K251357, K252707

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