MONARCH Platform (MON-000008)— 510(k) K260382
Substantially EquivalentAuris Health, Inc.
FDA 510(k) clearance K260382 for MONARCH Platform (MON-000008), Substantially Equivalent on 2026-07-25. Applicant: Auris Health, Inc.. Device class: 2.
Summary
Auris Health's MONARCH Platform (MON-000008) is filed under EOQ, flexible or rigid bronchoscopes. The record gives the model as MON-000008 but doesn't list the platform's components.
Class II, 21 CFR 874.4680. Ear, Nose, and Throat is both the classification panel and the review panel. It came in as a Traditional 510(k).
Auris Health filed from Santa Clara, California. The decision came 170 calendar days after receipt (February 5 to July 25, 2026).
Clearance details
- Applicant
- Auris Health, Inc.
- Product code
- Product code EOQ
- Device class
- Class 2
- Regulation
- 21 CFR 874.4680
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Clara, CA, US
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- K254037 — LungFlow Airway Catheter
- K253137 — FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T
More clearances from Auris Health, Inc.
view allAdverse events under product code EOQ
product code EOQ- Death
- 135
- Injury
- 2,863
- Malfunction
- 21,662
- Total
- 24,660
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.