Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

RELIEVA TRACT

Model RT1040AZ · ACCLARENT, INC. · DI 20705031462592

QGK — Balloon, Nasal Airway · Class I · 21 CFR 874.4420

UDILibrary device dossier · generated 2026-09-15 · 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.

13452020-09: 0 reports for this device; peer average 3/device2021-09: 0 reports for this device; peer average 3/device2022-06: 0 reports for this device; peer average 3/device2024-03: 0 reports for this device; peer average 5/device2024-04: 0 reports for this device; peer average 1/device2024-06: 0 reports for this device; peer average 3/device2024-09: 0 reports for this device; peer average 2/device09090603040609
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2020-0903
2021-0903
2022-0603
2024-0305
2024-0401
2024-0603
2024-0902
This device (reports/month)Average device in QGK (reports/device/month)

Regulatory clearances

  • K183090 SESE 2019-04-19 (k number procode)

Predicate lineage

K183090 — cited as predicate by K181546

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