510(k) · Cleared
ClearedMONARCH™ Platform (MON-000008)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Auris Health, Inc. · EOQ Bronchoscope (Flexible Or Rigid)
Cleared on Jul 25, 2026 as substantially equivalent to K243219 (Auris Health, Inc., 2025) after a 170-day review. Its family tree reaches back 6 generations to 1996.
- Decided
- Jul 25, 2026
- Review
- 170 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K955065 (1996). 10 ancestors in all, the oldest K914181 (1991). No later device cites it as a predicate yet.
- Root · 6 generations backK955065 Olympus FB Series Biopsy ForcepsOlympus America, Inc. · 1996
- 5 generations backK962555 Olympus FB Series Biopsy ForcepsOlympus America, Inc. · 1996
- 4 generations backK173760 Monarch Endoscopy Platform (Monarch Platform)Auris Surgical Robotics, Inc. · 2018 · Recalled
- 3 generations backK193534 Monarch PlatformAuris Health, Inc. · 2020 · Recalled
- 2 generations backK211493 Monarch PlatformAuris Health, Inc. · 2021 · Recalled
- 1 generation backK243219 MONARCH™ Platform (MON-000008)Auris Health, Inc. · 2025 · Recalled
- This deviceK260382 MONARCH™ Platform (MON-000008)Auris Health, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K955065 | Olympus FB Series Biopsy Forceps | Olympus America, Inc. | 1996 | — |
| −5 | K962555 | Olympus FB Series Biopsy Forceps | Olympus America, Inc. | 1996 | — |
| −4 | K173760 | Monarch Endoscopy Platform (Monarch Platform) | Auris Surgical Robotics, Inc. | 2018 | 1 |
| −3 | K193534 | Monarch Platform | Auris Health, Inc. | 2020 | 4 |
| −2 | K211493 | Monarch Platform | Auris Health, Inc. | 2021 | 2 |
| −1 | K243219 | MONARCH™ Platform (MON-000008) | Auris Health, Inc. | 2025 | 1 |
| 0 (this device) | K260382 | MONARCH™ Platform (MON-000008) | Auris Health, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 2007 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EOQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EOQ device
- #1 K223299 Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu®…score 18.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K243219 | MONARCH™ Platform (MON-000008)Summary page 5…EOQ Subsequent Product Code JAK [807.92(a)(3)] Legally Marketed Devices Predicate Device: MONARCH™ Platform 510(k) #: K243219 [807.92(a)(4)] Device Description Device Description: The MONARCH™ Platform is intended to provide bronchoscopic… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 5 of the 10 ancestors have a recall of any class.
How does its category compare?
All EOQ devicesEOQ Bronchoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · EOQ
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EOQ
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EOQ
25in 2025
Class I (28 since 2007) Class II/III not classified
Adverse event reports per year · EOQ
6,546in 2025
MAUDE reports naming product code EOQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 39 |
| 2008 | 2 | — | 0 | 87 |
| 2009 | 3 | 24 | 0 | 114 |
| 2010 | 0 | — | 0 | 100 |
| 2011 | 0 | — | 1 | 96 |
| 2012 | 2 | — | 4 | 93 |
| 2013 | 4 | 178 | 0 | 93 |
| 2014 | 3 | 302 | 0 | 98 |
| 2015 | 6 | 206 | 0 | 132 |
| 2016 | 3 | 262 | 1 | 297 |
| 2017 | 4 | 136 | 0 | 337 |
| 2018 | 7 | 212 | 0 | 279 |
| 2019 | 11 | 147 | 1 | 654 |
| 2020 | 10 | 103 | 1 | 515 |
| 2021 | 15 | 169 | 9 | 1,358 |
| 2022 | 11 | 134 | 5 | 2,541 |
| 2023 | 12 | 160 | 18 (4) | 5,064 |
| 2024 | 13 | 130 | 4 | 6,051 |
| 2025 | 20 | 147 | 25 (24) | 6,546 |
| 2026 | 9 | 206 | 0 | — |
What is it indicated for?
The MONARCH™ Bronchoscope and the Monarch Platform™ and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K260382 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260382: MONARCH™ Platform (MON-000008).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260382
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026