510(k) · Cleared
ClearedMonarch 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 Mar 11, 2021 as substantially equivalent to K193534 (Auris Health, Inc., 2020) after a 91-day review. Its family tree reaches back 4 generations to 1996. 1 later device descends from it.
- Decided
- Mar 11, 2021
- Review
- 91 days
- Class
- Class II
- Product code
- QNW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K955065 (1996). 8 ancestors in all, the oldest K914181 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK955065 Olympus FB Series Biopsy ForcepsOlympus America, Inc. · 1996
- 3 generations backK962555 Olympus FB Series Biopsy ForcepsOlympus America, Inc. · 1996
- 2 generations backK173760 Monarch Endoscopy Platform (Monarch Platform)Auris Surgical Robotics, Inc. · 2018 · Recalled
- 1 generation backK193534 Monarch PlatformAuris Health, Inc. · 2020 · Recalled
- This deviceK203614 Monarch BronchoscopeAuris Health, Inc., A Johnson and Johnson Family Company · 2021
- Descendant · cites it directly · 0 of its ownK231473 Monarch BronchoscopeAuris Health, Inc., A Johnson and Johnson Family Company · 2023 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K231473Monarch BronchoscopeAuris Health, Inc., A Johnson and Johnson Family Company · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K955065 | Olympus FB Series Biopsy Forceps | Olympus America, Inc. | 1996 | — |
| −3 | K962555 | Olympus FB Series Biopsy Forceps | Olympus America, Inc. | 1996 | — |
| −2 | K173760 | Monarch Endoscopy Platform (Monarch Platform) | Auris Surgical Robotics, Inc. | 2018 | 1 |
| −1 | K193534 | Monarch Platform | Auris Health, Inc. | 2020 | 4 |
| 0 (this device) | K203614 | Monarch Bronchoscope | Auris Health, Inc., A Johnson and Johnson Family Company | 2021 | — |
| +1 | K231473 | Monarch Bronchoscope | Auris Health, Inc., A Johnson and Johnson Family Company | 2023 | 1 |
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 |
|---|---|---|
| 2023 | 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 K231473 Monarch Bronchoscopescore 5.6 · 5 generations · no Class I recall
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 |
|---|---|---|---|
| * | K193534 | Monarch PlatformSummary page 4…e OEM Device: Proprietary Name Monarch Platform Common Name Bronchoscope (Flexible Or Rigid) Premarket Notification K193534 Classification Name Bronchoscope (flexible or rigid) and accessories Regulation Number 21 CFR 874… | 2020 |
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 |
|---|---|---|---|
| K231473 | Monarch Bronchoscope | 2023 | 0 |
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 25 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 3 of the 8 ancestors have a recall of any class.
- Of its descendants, K231473 (Auris Health, Inc., A Johnson and Johnson Family Company, 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K193534.
How does its category compare?
All QNW devicesQNW Reprocessed Bronchoscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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/K203614 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203614: 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/K203614
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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