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NuVent

Model 1830616EST · MEDTRONIC XOMED, INC. · DI 00763000416034

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

UDILibrary device dossier · generated 2026-09-11 · 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.

23562019-04: 0 reports for this device; peer average 2/device2020-09: 0 reports for this device; peer average 1/device2021-08: 0 reports for this device; peer average 3/device2021-10: 0 reports for this device; peer average 3/device2022-03: 0 reports for this device; peer average 6/device2022-06: 0 reports for this device; peer average 3/device2022-10: 0 reports for this device; peer average 1/device2022-12: 0 reports for this device; peer average 1/device2023-03: 0 reports for this device; peer average 1/device2023-05: 0 reports for this device; peer average 3/device2023-06: 0 reports for this device; peer average 6/device2023-08: 0 reports for this device; peer average 2/device2024-01: 0 reports for this device; peer average 2/device2024-02: 0 reports for this device; peer average 2/device2024-04: 0 reports for this device; peer average 2/device2024-07: 0 reports for this device; peer average 1/device2024-08: 0 reports for this device; peer average 2/device2025-05: 0 reports for this device; peer average 1/device2025-06: 0 reports for this device; peer average 1/device2025-12: 0 reports for this device; peer average 1/device0409081003061012030506080102040708050612
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0402
2020-0901
2021-0803
2021-1003
2022-0306
2022-0603
2022-1001
2022-1201
2023-0301
2023-0503
2023-0606
2023-0802
2024-0102
2024-0202
2024-0402
2024-0701
2024-0802
2025-0501
2025-0601
2025-1201
This device (reports/month)Average device in PNZ (reports/device/month)

Regulatory clearances

  • K210841 SESE 2021-08-16 (k number procode)

Predicate lineage

K210841 — cites (transitively): DEN150056 (d1), K132297 (d1), K152434 (d1), K163509 (d1), K171761 (d1), K142252 (d2), K132440 (d3)

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

Manufacturer compliance record — MEDTRONIC XOMED, INC.

  • VAI 2024-06-17 Medtronic Xomed, Inc. · 1 citations
  • VAI 2021-10-29 Medtronic Xomed, Inc. · 5 citations
  • VAI 2015-09-21 Medtronic Xomed, Inc. · 1 citations
  • VAI 2012-07-03 Medtronic Xomed, Inc. · 8 citations
  • NAI 2012-06-06 Medtronic Xomed, Inc. · 0 citations
  • VAI 2010-08-05 Medtronic Xomed, Inc. · 4 citations