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

Monarch Platform, Bronchoscopy

Model MON-000008 · Auris Health, Inc. · DI 10810068810988

EOQ — Bronchoscope (Flexible Or Rigid) · Class II · 21 CFR 874.4680

JAK — System, X-Ray, Tomography, Computed · Class II · 21 CFR 892.1750

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 (1)

InitiatedRecall #ClassStatusReasonLink basis
2026-01-21Z-1383-2026Class IIOpen, ClassifiedDevice for bronchoscopic visualization, patient airway access has software issue: if application restarts after patient-side selection, prior to bronchoscope loading, application will re-initialize to patient-left position; and if right position was previously selected, this may lead to unanticipated robotic arm positioning toward patient-left, may result in contact with patient/endotracheal tube.code info di

Adverse-event reports — MAUDE (3)

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: 2 · Injury: 1

4812162019-01: 0 reports for this device; peer average 3.15/device2019-02: 0 reports for this device; peer average 2.5/device2019-03: 0 reports for this device; peer average 5.48/device2019-04: 0 reports for this device; peer average 16.27/device2019-05: 0 reports for this device; peer average 3.61/device2019-06: 0 reports for this device; peer average 2.9/device2019-07: 0 reports for this device; peer average 2.56/device2019-08: 0 reports for this device; peer average 3.75/device2019-09: 0 reports for this device; peer average 2.5/device2019-10: 0 reports for this device; peer average 2.37/device2019-11: 0 reports for this device; peer average 2.18/device2019-12: 0 reports for this device; peer average 4.71/device2020-01: 0 reports for this device; peer average 2.5/device2020-02: 0 reports for this device; peer average 4.32/device2020-03: 0 reports for this device; peer average 2.27/device2020-04: 0 reports for this device; peer average 4.19/device2020-05: 0 reports for this device; peer average 2.58/device2020-06: 0 reports for this device; peer average 3.62/device2020-07: 0 reports for this device; peer average 3.35/device2020-08: 0 reports for this device; peer average 2.91/device2020-09: 0 reports for this device; peer average 2.95/device2020-10: 0 reports for this device; peer average 3.19/device2020-11: 0 reports for this device; peer average 3.67/device2020-12: 0 reports for this device; peer average 4.92/device2021-01: 0 reports for this device; peer average 3.4/device2021-02: 0 reports for this device; peer average 3.04/device2021-03: 0 reports for this device; peer average 4.43/device2021-04: 0 reports for this device; peer average 3.89/device2021-05: 0 reports for this device; peer average 4.53/device2021-06: 0 reports for this device; peer average 4.19/device2021-07: 0 reports for this device; peer average 3.18/device2021-08: 0 reports for this device; peer average 4/device2021-09: 0 reports for this device; peer average 3.48/device2021-10: 0 reports for this device; peer average 3.84/device2021-11: 0 reports for this device; peer average 3.48/device2021-12: 0 reports for this device; peer average 4.14/device2022-01: 0 reports for this device; peer average 4.11/device2022-02: 0 reports for this device; peer average 4/device2022-03: 0 reports for this device; peer average 5.42/device2022-04: 0 reports for this device; peer average 5.5/device2022-05: 0 reports for this device; peer average 5.16/device2022-06: 0 reports for this device; peer average 4.75/device2022-07: 0 reports for this device; peer average 5.57/device2022-08: 0 reports for this device; peer average 4.8/device2022-09: 0 reports for this device; peer average 4.56/device2022-10: 0 reports for this device; peer average 5/device2022-11: 0 reports for this device; peer average 4.97/device2022-12: 0 reports for this device; peer average 4.89/device2023-01: 0 reports for this device; peer average 6.88/device2023-02: 0 reports for this device; peer average 4.82/device2023-03: 0 reports for this device; peer average 6.39/device2023-04: 0 reports for this device; peer average 5.47/device2023-05: 0 reports for this device; peer average 5.6/device2023-06: 0 reports for this device; peer average 6.44/device2023-07: 0 reports for this device; peer average 5.21/device2023-08: 0 reports for this device; peer average 6.32/device2023-09: 0 reports for this device; peer average 5.97/device2023-10: 0 reports for this device; peer average 6.56/device2023-11: 0 reports for this device; peer average 6.24/device2023-12: 0 reports for this device; peer average 6.12/device2024-01: 1 reports for this device; peer average 5.8/device2024-02: 0 reports for this device; peer average 5.32/device2024-03: 0 reports for this device; peer average 6.14/device2024-04: 0 reports for this device; peer average 5.33/device2024-05: 0 reports for this device; peer average 5.3/device2024-06: 0 reports for this device; peer average 6.54/device2024-07: 0 reports for this device; peer average 5.29/device2024-08: 0 reports for this device; peer average 6.8/device2024-09: 0 reports for this device; peer average 6.15/device2024-10: 0 reports for this device; peer average 6.67/device2024-11: 0 reports for this device; peer average 8.77/device2024-12: 0 reports for this device; peer average 3.63/device2025-01: 0 reports for this device; peer average 3.43/device2025-02: 0 reports for this device; peer average 3.08/device2025-03: 0 reports for this device; peer average 3.36/device2025-04: 0 reports for this device; peer average 3.7/device2025-05: 0 reports for this device; peer average 4.57/device2025-06: 0 reports for this device; peer average 4.17/device2025-07: 0 reports for this device; peer average 4.7/device2025-08: 0 reports for this device; peer average 4.3/device2025-09: 0 reports for this device; peer average 3.83/device2025-10: 0 reports for this device; peer average 4.58/device2025-11: 0 reports for this device; peer average 5.2/device2025-12: 0 reports for this device; peer average 8.42/device2026-01: 0 reports for this device; peer average 7.63/device2026-02: 1 reports for this device; peer average 5.27/device2026-03: 0 reports for this device; peer average 5.85/device2026-04: 0 reports for this device; peer average 7.26/device2026-05: 0 reports for this device; peer average 7.81/device2026-06: 1 reports for this device; peer average 6.19/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0103.15
2019-0202.5
2019-0305.48
2019-04016.27
2019-0503.61
2019-0602.9
2019-0702.56
2019-0803.75
2019-0902.5
2019-1002.37
2019-1102.18
2019-1204.71
2020-0102.5
2020-0204.32
2020-0302.27
2020-0404.19
2020-0502.58
2020-0603.62
2020-0703.35
2020-0802.91
2020-0902.95
2020-1003.19
2020-1103.67
2020-1204.92
2021-0103.4
2021-0203.04
2021-0304.43
2021-0403.89
2021-0504.53
2021-0604.19
2021-0703.18
2021-0804
2021-0903.48
2021-1003.84
2021-1103.48
2021-1204.14
2022-0104.11
2022-0204
2022-0305.42
2022-0405.5
2022-0505.16
2022-0604.75
2022-0705.57
2022-0804.8
2022-0904.56
2022-1005
2022-1104.97
2022-1204.89
2023-0106.88
2023-0204.82
2023-0306.39
2023-0405.47
2023-0505.6
2023-0606.44
2023-0705.21
2023-0806.32
2023-0905.97
2023-1006.56
2023-1106.24
2023-1206.12
2024-0115.8
2024-0205.32
2024-0306.14
2024-0405.33
2024-0505.3
2024-0606.54
2024-0705.29
2024-0806.8
2024-0906.15
2024-1006.67
2024-1108.77
2024-1203.63
2025-0103.43
2025-0203.08
2025-0303.36
2025-0403.7
2025-0504.57
2025-0604.17
2025-0704.7
2025-0804.3
2025-0903.83
2025-1004.58
2025-1105.2
2025-1208.42
2026-0107.63
2026-0215.27
2026-0305.85
2026-0407.26
2026-0507.81
2026-0616.19
This device (reports/month)Average device in EOQ, JAK (reports/device/month)

Regulatory clearances

  • K260382 SESE 2026-07-25 (k number procode)

Predicate lineage

K243219 — cites (transitively): K211493 (d1), K223144 (d1), K193534 (d2), K173244 (d2), K173760 (d2), K151376 (d3), K071530 (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 K260382

K260382 — cites (transitively): K243219 (d1), K260328 (d1), K211493 (d2), K223144 (d2), K193534 (d3), K173244 (d3), K173760 (d3), K151376 (d4), K071530 (d4), K152319 (d4), K162611 (d4), K834402 (d4), K860582 (d4), K925392 (d4), K944650 (d4), K962555 (d4), K102604 (d5), K052480 (d5), K121959 (d5), K904667 (d5), K914181 (d5), K092365 (d6), K051645 (d6), K061313 (d6), K062049 (d6), K100584 (d6)

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