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Monarch Endoscopy Platform (P1) Tower Upgrade

Model MON-000005-01 · Auris Health, Inc. · DI B634MON000005010

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 2026-09-07 · 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 (38)

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.

Injury: 22 · Malfunction: 15 · Death: 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: 2 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: 3 reports for this device; peer average 4.75/device2022-07: 5 reports for this device; peer average 5.57/device2022-08: 1 reports for this device; peer average 4.8/device2022-09: 2 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: 2 reports for this device; peer average 4.82/device2023-03: 2 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: 3 reports for this device; peer average 6.32/device2023-09: 3 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: 0 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: 3 reports for this device; peer average 5.3/device2024-06: 0 reports for this device; peer average 6.54/device2024-07: 2 reports for this device; peer average 5.29/device2024-08: 0 reports for this device; peer average 6.8/device2024-09: 2 reports for this device; peer average 6.15/device2024-10: 2 reports for this device; peer average 6.67/device2024-11: 2 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: 3 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: 0 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
2021-1123.48
2021-1204.14
2022-0104.11
2022-0204
2022-0305.42
2022-0405.5
2022-0505.16
2022-0634.75
2022-0755.57
2022-0814.8
2022-0924.56
2022-1005
2022-1104.97
2022-1204.89
2023-0106.88
2023-0224.82
2023-0326.39
2023-0405.47
2023-0505.6
2023-0606.44
2023-0705.21
2023-0836.32
2023-0935.97
2023-1006.56
2023-1106.24
2023-1206.12
2024-0105.8
2024-0205.32
2024-0306.14
2024-0405.33
2024-0535.3
2024-0606.54
2024-0725.29
2024-0806.8
2024-0926.15
2024-1026.67
2024-1128.77
2024-1203.63
2025-0103.43
2025-0233.08
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
2026-0205.27
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

  • None linked in the loaded window.

Predicate lineage

K173760 — cites (transitively): K071530 (d1), K151376 (d1), K152319 (d1), K162611 (d1), K834402 (d1), K860582 (d1), K925392 (d1), K944650 (d1), K962555 (d1), K102604 (d2), K052480 (d2), K121959 (d2), K904667 (d2), K914181 (d2), K092365 (d3), K051645 (d3), K061313 (d3), K062049 (d3), K100584 (d3) — cited as predicate by K182188, K193534, K223144

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