510(k) · Cleared
Recalled · Class II · 2026MONARCH™ 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 Jan 23, 2025 as substantially equivalent to K211493 (Auris Health, Inc., 2021) after a 108-day review. Its family tree reaches back 5 generations to 1996. 1 later device descends from it. It has been recalled once.
- Decided
- Jan 23, 2025
- Review
- 108 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K955065 (1996). 9 ancestors in all, the oldest K914181 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK955065 Olympus FB Series Biopsy ForcepsOlympus America, Inc. · 1996
- 4 generations backK962555 Olympus FB Series Biopsy ForcepsOlympus America, Inc. · 1996
- 3 generations backK173760 Monarch Endoscopy Platform (Monarch Platform)Auris Surgical Robotics, Inc. · 2018 · Recalled
- 2 generations backK193534 Monarch PlatformAuris Health, Inc. · 2020 · Recalled
- 1 generation backK211493 Monarch PlatformAuris Health, Inc. · 2021 · Recalled
- This deviceK243219 MONARCH™ Platform (MON-000008)Auris Health, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK260382 MONARCH™ Platform (MON-000008)Auris Health, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K260382MONARCH™ Platform (MON-000008)Auris Health, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K955065 | Olympus FB Series Biopsy Forceps | Olympus America, Inc. | 1996 | — |
| −4 | K962555 | Olympus FB Series Biopsy Forceps | Olympus America, Inc. | 1996 | — |
| −3 | K173760 | Monarch Endoscopy Platform (Monarch Platform) | Auris Surgical Robotics, Inc. | 2018 | 1 |
| −2 | K193534 | Monarch Platform | Auris Health, Inc. | 2020 | 4 |
| −1 | K211493 | Monarch Platform | Auris Health, Inc. | 2021 | 2 |
| 0 (this device) | K243219 | MONARCH™ Platform (MON-000008) | Auris Health, Inc. | 2025 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K211493 | Monarch PlatformSummary page 5…EOQ Subsequent Product Code JAK [807.92(a)(3)] Legally Marketed Devices Predicate Device: MONARCH Platform 510(k) #: K211493 [807.92(a)(4)] Device Description Device Description: The MONARCH Platform is intended to provide bronchoscopic… | 2021 |
| † | K223144 | Galaxy System | 2023 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260382 | MONARCH™ Platform (MON-000008) | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 21, 2026 | Class II | Z-1383-2026 | Software design | Device 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… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 4 of the 9 ancestors have a recall of any class.
- Of its descendants, K260382 (Auris Health, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All EOQ devicesEOQ Bronchoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 as stated in the FDA summary.
https://510kreport.com/device/K243219 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243219: 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/K243219
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026