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MONARCH™Platform, Urology

Model MON-000007 · Auris Health, Inc. · DI 10810068811046

FGB — Ureteroscope And Accessories, Flexible/Rigid · Class II · 21 CFR 876.1500

LJH — System, Irrigation, Urological · Class II · 21 CFR 876.5130

UDILibrary device dossier · generated 2026-09-13 · 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
2024-08-02Z-0052-2025Class IIOpen, ClassifiedEndoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords that may cause an electrical short, which may lead to system shutdown, which can lead to prolonged procedure or case conversion, and if the user (e.g., operating room staff) touches exposed wires or conductive fluids in contact with the exposed wires, there is a chance of electrical shock.k number procode

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.

Injury: 3

4812162019-01: 0 reports for this device; peer average 1/device2019-02: 0 reports for this device; peer average 1/device2019-04: 0 reports for this device; peer average 1/device2019-05: 0 reports for this device; peer average 2.25/device2019-06: 0 reports for this device; peer average 1/device2019-07: 0 reports for this device; peer average 1.33/device2019-08: 0 reports for this device; peer average 2.8/device2019-09: 0 reports for this device; peer average 2/device2019-10: 0 reports for this device; peer average 1.25/device2019-11: 0 reports for this device; peer average 1.33/device2019-12: 0 reports for this device; peer average 1.4/device2020-01: 0 reports for this device; peer average 1.5/device2020-02: 0 reports for this device; peer average 2.6/device2020-04: 0 reports for this device; peer average 2.5/device2020-05: 0 reports for this device; peer average 2.25/device2020-06: 0 reports for this device; peer average 3.42/device2020-07: 0 reports for this device; peer average 3.59/device2020-08: 0 reports for this device; peer average 4.67/device2020-09: 0 reports for this device; peer average 3.75/device2020-10: 0 reports for this device; peer average 7.5/device2020-11: 0 reports for this device; peer average 7.5/device2020-12: 0 reports for this device; peer average 4.95/device2021-01: 0 reports for this device; peer average 6.08/device2021-02: 0 reports for this device; peer average 5.62/device2021-03: 0 reports for this device; peer average 7.92/device2021-04: 0 reports for this device; peer average 8.33/device2021-05: 0 reports for this device; peer average 5.44/device2021-06: 0 reports for this device; peer average 4.73/device2021-07: 0 reports for this device; peer average 4.93/device2021-08: 0 reports for this device; peer average 7/device2021-09: 0 reports for this device; peer average 6.13/device2021-10: 0 reports for this device; peer average 5.56/device2021-11: 0 reports for this device; peer average 6.69/device2021-12: 0 reports for this device; peer average 6.47/device2022-01: 0 reports for this device; peer average 8.16/device2022-02: 0 reports for this device; peer average 10.11/device2022-03: 0 reports for this device; peer average 13.13/device2022-04: 0 reports for this device; peer average 16.29/device2022-05: 0 reports for this device; peer average 12.16/device2022-06: 0 reports for this device; peer average 13.61/device2022-07: 0 reports for this device; peer average 13.61/device2022-08: 0 reports for this device; peer average 15.76/device2022-09: 0 reports for this device; peer average 12.17/device2022-10: 0 reports for this device; peer average 10.9/device2022-11: 0 reports for this device; peer average 10.41/device2022-12: 0 reports for this device; peer average 11.94/device2023-01: 0 reports for this device; peer average 11.14/device2023-02: 0 reports for this device; peer average 7.52/device2023-03: 0 reports for this device; peer average 11.57/device2023-04: 0 reports for this device; peer average 12/device2023-05: 0 reports for this device; peer average 8.4/device2023-06: 0 reports for this device; peer average 10.13/device2023-07: 0 reports for this device; peer average 8.27/device2023-08: 0 reports for this device; peer average 10.2/device2023-09: 0 reports for this device; peer average 11.52/device2023-10: 0 reports for this device; peer average 10.52/device2023-11: 0 reports for this device; peer average 10.57/device2023-12: 0 reports for this device; peer average 7.78/device2024-01: 0 reports for this device; peer average 7.22/device2024-02: 1 reports for this device; peer average 8.83/device2024-03: 0 reports for this device; peer average 9.24/device2024-04: 0 reports for this device; peer average 7.37/device2024-05: 0 reports for this device; peer average 6.67/device2024-06: 2 reports for this device; peer average 8.32/device2024-07: 0 reports for this device; peer average 8.96/device2024-08: 0 reports for this device; peer average 9/device2024-09: 0 reports for this device; peer average 7.93/device2024-10: 0 reports for this device; peer average 9.75/device2024-11: 0 reports for this device; peer average 5.89/device2024-12: 0 reports for this device; peer average 4.84/device2025-01: 0 reports for this device; peer average 3/device2025-02: 0 reports for this device; peer average 2.45/device2025-03: 0 reports for this device; peer average 4.14/device2025-04: 0 reports for this device; peer average 3.9/device2025-05: 0 reports for this device; peer average 3.52/device2025-06: 0 reports for this device; peer average 3.74/device2025-07: 0 reports for this device; peer average 4.08/device2025-08: 0 reports for this device; peer average 4.71/device2025-09: 0 reports for this device; peer average 3.55/device2025-10: 0 reports for this device; peer average 4.69/device2025-11: 0 reports for this device; peer average 3.5/device2025-12: 0 reports for this device; peer average 6.72/device2026-01: 0 reports for this device; peer average 8.54/device2026-02: 0 reports for this device; peer average 5.79/device2026-03: 0 reports for this device; peer average 5.25/device2026-04: 0 reports for this device; peer average 6.95/device2026-05: 0 reports for this device; peer average 8.17/device2026-06: 0 reports for this device; peer average 6.81/device01020405060708091011120102040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2019-0201
2019-0401
2019-0502.25
2019-0601
2019-0701.33
2019-0802.8
2019-0902
2019-1001.25
2019-1101.33
2019-1201.4
2020-0101.5
2020-0202.6
2020-0402.5
2020-0502.25
2020-0603.42
2020-0703.59
2020-0804.67
2020-0903.75
2020-1007.5
2020-1107.5
2020-1204.95
2021-0106.08
2021-0205.62
2021-0307.92
2021-0408.33
2021-0505.44
2021-0604.73
2021-0704.93
2021-0807
2021-0906.13
2021-1005.56
2021-1106.69
2021-1206.47
2022-0108.16
2022-02010.11
2022-03013.13
2022-04016.29
2022-05012.16
2022-06013.61
2022-07013.61
2022-08015.76
2022-09012.17
2022-10010.9
2022-11010.41
2022-12011.94
2023-01011.14
2023-0207.52
2023-03011.57
2023-04012
2023-0508.4
2023-06010.13
2023-0708.27
2023-08010.2
2023-09011.52
2023-10010.52
2023-11010.57
2023-1207.78
2024-0107.22
2024-0218.83
2024-0309.24
2024-0407.37
2024-0506.67
2024-0628.32
2024-0708.96
2024-0809
2024-0907.93
2024-1009.75
2024-1105.89
2024-1204.84
2025-0103
2025-0202.45
2025-0304.14
2025-0403.9
2025-0503.52
2025-0603.74
2025-0704.08
2025-0804.71
2025-0903.55
2025-1004.69
2025-1103.5
2025-1206.72
2026-0108.54
2026-0205.79
2026-0305.25
2026-0406.95
2026-0508.17
2026-0606.81
This device (reports/month)Average device in FGB, LJH (reports/device/month)

Regulatory clearances

  • K213334 SESE 2022-04-29 (k number procode)

Predicate lineage

K213334 — cites (transitively): K141250 (d1), K153049 (d1), K162992 (d1), K172048 (d1), K172527 (d1), K172929 (d1), K193534 (d1), K994223 (d1), K131369 (d2), K135319 (d2), K033651 (d2), K060269 (d2), K010569 (d2), K981615 (d2), K040094 (d2), K072080 (d2), K133799 (d2), K820865 (d2), K851144 (d2), K024050 (d2), K173760 (d2), K003325 (d3), K132799 (d3), 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)

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