510(k) · Cleared
Recalled · Class II · 2025Monarch Bronchoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Auris Health, Inc., A Johnson and Johnson Family Company · QNW Reprocessed Bronchoscope
Cleared on Nov 28, 2023 as substantially equivalent to K203614 (Auris Health, Inc., A Johnson and Johnson Family Company, 2021) and 1 other predicate after a 190-day review. Its family tree reaches back 5 generations to 1996. It has been recalled once.
- Decided
- Nov 28, 2023
- Review
- 190 days
- Class
- Class II
- Product code
- QNW
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to K955065 (1996). 9 ancestors in all, the oldest K914181 (1991). No later device cites it as a predicate yet.
- 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 backK203614 Monarch BronchoscopeAuris Health, Inc., A Johnson and Johnson Family Company · 2021
- This deviceK231473 Monarch BronchoscopeAuris Health, Inc., A Johnson and Johnson Family Company · 2023
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 | K203614 | Monarch Bronchoscope | Auris Health, Inc., A Johnson and Johnson Family Company | 2021 | — |
| 0 (this device) | K231473 | Monarch Bronchoscope | Auris Health, Inc., A Johnson and Johnson Family Company | 2023 | — |
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 QNW? 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 QNW device
- #1 K203614 Monarch Bronchoscopescore 4.9 · 4 generations · no Class I recall
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K203614 | Monarch BronchoscopeSummary page 4…e: Proprietary Name Monarch Bronchoscope Common Name Reprocessed Bronchoscope Premarket Notification K203614 Classification Name Bronchoscope (flexible or rigid) and accessories Regulation Number… | 2021 |
| * | K193534 | Monarch PlatformSummary page 5…roprietary Name Monarch Platform Common Name Bronchoscope (Flexible or Rigid) Premarket Notification K193534 Classification Name Bronchoscope (flexible or rigid) and accessories Regulation Number… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 18, 2025 | Class II | Z-0543-2026 | Process control | Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 3 of the 9 ancestors have a recall of any class.
How does its category compare?
All QNW devicesQNW Reprocessed Bronchoscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QNW
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QNW
Too few QNW 510(k)s in any year since 2007 to give a median.
Recalls per year · QNW
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QNW
2in 2025
MAUDE reports naming product code QNW, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 1 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The reprocessed Monarch Bronchoscope, used in conjunction with the Monarch Platform, is 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/K231473 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231473: Monarch Bronchoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231473
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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