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Monarch Bronchoscope

Model MBR-000211-B · Auris Health, Inc. · DI B634MBR000211B0

QNW — Reprocessed Bronchoscope · Class II · 21 CFR 874.4680

UDILibrary device dossier · generated 2026-09-14 · 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 (14)

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.

Malfunction: 9 · Injury: 5

12232022-09: 3 reports for this device; peer average 2.5/device2023-03: 3 reports for this device; peer average 2.5/device2024-01: 3 reports for this device; peer average 2.5/device2024-10: 1 reports for this device; peer average 1/device2026-01: 2 reports for this device; peer average 2/device2026-03: 2 reports for this device; peer average 2/device090301100103
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2022-0932.5
2023-0332.5
2024-0132.5
2024-1011
2026-0122
2026-0322
This device (reports/month)Average device in QNW (reports/device/month)

Regulatory clearances

  • K203614 SESE 2021-03-11 (k number procode)

Predicate lineage

K203614 — cites (transitively): K193534 (d1), K173760 (d2), K071530 (d3), K151376 (d3), K152319 (d3), K162611 (d3), K834402 (d3), K860582 (d3), K925392 (d3), K944650 (d3), K962555 (d3), K102604 (d4), K052480 (d4), K121959 (d4), K904667 (d4), K914181 (d4), K092365 (d5), K051645 (d5), K061313 (d5), K062049 (d5), K100584 (d5) — cited as predicate by K231473

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

Manufacturer compliance record — Auris Health, Inc.

  • NAI 2020-02-07 Auris Health Inc. · 0 citations
  • NAI 2020-02-06 AURIS HEALTH INC · 0 citations
  • NAI 2020-02-06 AURIS HEALTH INC · 0 citations
  • NAI 2017-07-11 Auris Health Inc. · 0 citations
  • NAI 2017-02-13 Auris Health Inc. · 0 citations