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ACCLARENT PIVOT

Model PVT0616 · ACCLARENT, INC. · DI 10705031465565

LRC — Instrument, Ent Manual Surgical · Class I · 21 CFR 874.4420

PGW — Ear, Nose, And Throat Stereotaxic Instrument · Class II · 21 CFR 882.4560

PNZ — Eustachian Tube Balloon Dilation Device · Class II · 21 CFR 874.4180

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.

61117222019-01: 0 reports for this device; peer average 2.83/device2019-02: 0 reports for this device; peer average 3/device2019-03: 0 reports for this device; peer average 4/device2019-04: 0 reports for this device; peer average 2.45/device2019-05: 0 reports for this device; peer average 22/device2019-06: 0 reports for this device; peer average 4.25/device2019-07: 0 reports for this device; peer average 4.33/device2019-08: 0 reports for this device; peer average 7/device2019-09: 0 reports for this device; peer average 1.8/device2019-10: 0 reports for this device; peer average 1.6/device2019-11: 0 reports for this device; peer average 1.25/device2019-12: 0 reports for this device; peer average 2.33/device2020-01: 0 reports for this device; peer average 1.4/device2020-02: 0 reports for this device; peer average 2.38/device2020-03: 0 reports for this device; peer average 4/device2020-04: 0 reports for this device; peer average 1.67/device2020-05: 0 reports for this device; peer average 1.5/device2020-06: 0 reports for this device; peer average 2.5/device2020-07: 0 reports for this device; peer average 3/device2020-08: 0 reports for this device; peer average 4.33/device2020-09: 0 reports for this device; peer average 1.2/device2020-10: 0 reports for this device; peer average 6/device2020-11: 0 reports for this device; peer average 1.71/device2020-12: 0 reports for this device; peer average 3.67/device2021-01: 0 reports for this device; peer average 3/device2021-02: 0 reports for this device; peer average 3/device2021-03: 0 reports for this device; peer average 6/device2021-04: 0 reports for this device; peer average 5.33/device2021-05: 0 reports for this device; peer average 7.67/device2021-06: 0 reports for this device; peer average 5/device2021-07: 0 reports for this device; peer average 4.8/device2021-08: 0 reports for this device; peer average 3.58/device2021-09: 0 reports for this device; peer average 2.86/device2021-10: 0 reports for this device; peer average 3/device2021-11: 0 reports for this device; peer average 3/device2021-12: 0 reports for this device; peer average 2.83/device2022-01: 0 reports for this device; peer average 2.29/device2022-02: 0 reports for this device; peer average 3.5/device2022-03: 0 reports for this device; peer average 4.71/device2022-04: 0 reports for this device; peer average 3/device2022-05: 0 reports for this device; peer average 4.5/device2022-06: 0 reports for this device; peer average 2.92/device2022-07: 0 reports for this device; peer average 3.6/device2022-08: 0 reports for this device; peer average 2.67/device2022-09: 0 reports for this device; peer average 2.09/device2022-10: 0 reports for this device; peer average 2.8/device2022-11: 0 reports for this device; peer average 6.09/device2022-12: 0 reports for this device; peer average 1.5/device2023-01: 0 reports for this device; peer average 4.83/device2023-02: 0 reports for this device; peer average 2.7/device2023-03: 0 reports for this device; peer average 2.62/device2023-04: 0 reports for this device; peer average 3.44/device2023-05: 0 reports for this device; peer average 4.5/device2023-06: 0 reports for this device; peer average 3.5/device2023-07: 0 reports for this device; peer average 3.5/device2023-08: 0 reports for this device; peer average 3.14/device2023-09: 0 reports for this device; peer average 2.89/device2023-10: 0 reports for this device; peer average 2.5/device2023-11: 0 reports for this device; peer average 2.84/device2023-12: 0 reports for this device; peer average 3.9/device2024-01: 0 reports for this device; peer average 1.82/device2024-02: 0 reports for this device; peer average 2.67/device2024-03: 0 reports for this device; peer average 2.85/device2024-04: 0 reports for this device; peer average 3.64/device2024-05: 0 reports for this device; peer average 5.13/device2024-06: 0 reports for this device; peer average 2/device2024-07: 0 reports for this device; peer average 2.53/device2024-08: 0 reports for this device; peer average 5.5/device2024-09: 0 reports for this device; peer average 2.15/device2024-10: 0 reports for this device; peer average 3.85/device2024-11: 0 reports for this device; peer average 4.83/device2024-12: 0 reports for this device; peer average 3.86/device2025-01: 0 reports for this device; peer average 1.71/device2025-02: 0 reports for this device; peer average 4.05/device2025-03: 0 reports for this device; peer average 3.56/device2025-04: 0 reports for this device; peer average 2.07/device2025-05: 0 reports for this device; peer average 3/device2025-06: 0 reports for this device; peer average 4.2/device2025-07: 0 reports for this device; peer average 1.75/device2025-08: 0 reports for this device; peer average 4/device2025-09: 0 reports for this device; peer average 2/device2025-10: 0 reports for this device; peer average 2.17/device2025-11: 0 reports for this device; peer average 2.6/device2025-12: 0 reports for this device; peer average 1.77/device2026-01: 0 reports for this device; peer average 1.92/device2026-02: 0 reports for this device; peer average 2/device2026-03: 0 reports for this device; peer average 5/device2026-04: 0 reports for this device; peer average 1.36/device2026-05: 0 reports for this device; peer average 2.33/device2026-06: 0 reports for this device; peer average 1.67/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.83
2019-0203
2019-0304
2019-0402.45
2019-05022
2019-0604.25
2019-0704.33
2019-0807
2019-0901.8
2019-1001.6
2019-1101.25
2019-1202.33
2020-0101.4
2020-0202.38
2020-0304
2020-0401.67
2020-0501.5
2020-0602.5
2020-0703
2020-0804.33
2020-0901.2
2020-1006
2020-1101.71
2020-1203.67
2021-0103
2021-0203
2021-0306
2021-0405.33
2021-0507.67
2021-0605
2021-0704.8
2021-0803.58
2021-0902.86
2021-1003
2021-1103
2021-1202.83
2022-0102.29
2022-0203.5
2022-0304.71
2022-0403
2022-0504.5
2022-0602.92
2022-0703.6
2022-0802.67
2022-0902.09
2022-1002.8
2022-1106.09
2022-1201.5
2023-0104.83
2023-0202.7
2023-0302.62
2023-0403.44
2023-0504.5
2023-0603.5
2023-0703.5
2023-0803.14
2023-0902.89
2023-1002.5
2023-1102.84
2023-1203.9
2024-0101.82
2024-0202.67
2024-0302.85
2024-0403.64
2024-0505.13
2024-0602
2024-0702.53
2024-0805.5
2024-0902.15
2024-1003.85
2024-1104.83
2024-1203.86
2025-0101.71
2025-0204.05
2025-0303.56
2025-0402.07
2025-0503
2025-0604.2
2025-0701.75
2025-0804
2025-0902
2025-1002.17
2025-1102.6
2025-1201.77
2026-0101.92
2026-0202
2026-0305
2026-0401.36
2026-0502.33
2026-0601.67
This device (reports/month)Average device in LRC, PGW, PNZ (reports/device/month)

Regulatory clearances

  • K201115 SESE 2020-08-27 (k number procode)

Predicate lineage

K201115 — cites (transitively): K143541 (d1), K171687 (d1), K171761 (d1), K190532 (d1), K071845 (d2), K111254 (d2), K111875 (d2), K152121 (d2), K161697 (d2), K161698 (d2), K161701 (d2), DEN150056 (d2), K163509 (d2), K073041 (d3), K102003 (d3), K132297 (d3), K141456 (d3), K133573 (d3), K133916 (d3), K152434 (d3), K093007 (d4), K001284 (d4), K960330 (d4), K964229 (d4), K983529 (d4), K130721 (d4), K133665 (d4), K142252 (d4), K050438 (d5), K132440 (d5)

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

Manufacturer compliance record — ACCLARENT, INC.

  • Warning Letter 2013-03-20 Acclarent, Inc.
  • Warning Letter 2013-03-20 Acclarent, Inc.
  • Warning Letter 2012-06-14 Acclarent, Inc.
  • Warning Letter 2012-06-14 Acclarent, Inc.
  • NAI 2020-09-25 Acclarent, Inc. · 0 citations
  • NAI 2020-09-25 Acclarent, Inc. · 0 citations
  • VAI 2013-12-09 Acclarent, Inc. · 0 citations
  • VAI 2013-12-09 Acclarent, Inc. · 0 citations
  • OAI 2013-02-22 Acclarent, Inc. · 2 citations
  • OAI 2013-02-22 Acclarent, Inc. · 2 citations
  • OAI 2012-02-24 Acclarent, Inc. · 3 citations
  • OAI 2012-02-24 Acclarent, Inc. · 3 citations