510(k) · Cleared
Recalled · Class II · 2019Monarch Endoscopy Platform (Monarch Platform)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Auris Surgical Robotics, Inc. · EOQ Bronchoscope (Flexible Or Rigid)
Cleared on Mar 22, 2018 as substantially equivalent to K071530 (KARL STORZ Endoscopy-America, Inc., 2007) and 3 other predicates after a 101-day review. Its family tree reaches back 2 generations to 1996. 7 later devices descend from it. It has been recalled once.
- Decided
- Mar 22, 2018
- Review
- 101 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 2 generations to K955065 (1996). 6 ancestors in all, the oldest K914181 (1991). 7 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK955065 Olympus FB Series Biopsy ForcepsOlympus America, Inc. · 1996
- 1 generation backK962555 Olympus FB Series Biopsy ForcepsOlympus America, Inc. · 1996
- This deviceK173760 Monarch Endoscopy Platform (Monarch Platform)Auris Surgical Robotics, Inc. · 2018
- Descendant · cites it directly · 5 of its ownK193534 Monarch PlatformAuris Health, Inc. · 2020 · Recalled
- Descendant · 2 generations on · 2 of its ownK211493 Monarch PlatformAuris Health, Inc. · 2021 · Recalled
- Descendant · 3 generations on · 1 of its ownK243219 MONARCH™ Platform (MON-000008)Auris Health, Inc. · 2025 · Recalled
- Descendant · 2 generations on · 1 of its ownK203614 Monarch BronchoscopeAuris Health, Inc., A Johnson and Johnson Family Company · 2021
- Descendant · 4 generations on · 0 of its ownK260382 MONARCH™ Platform (MON-000008)Auris Health, Inc. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K193534Monarch PlatformAuris Health, Inc. · 2020 · cites it directly5descendants
- K211493Monarch PlatformAuris Health, Inc. · 2021 · 2 generations on2descendants
- K243219MONARCH™ Platform (MON-000008)Auris Health, Inc. · 2025 · 3 generations on1descendant
- K203614Monarch BronchoscopeAuris Health, Inc., A Johnson and Johnson Family Company · 2021 · 2 generations on1descendant
- K260382MONARCH™ Platform (MON-000008)Auris Health, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K955065 | Olympus FB Series Biopsy Forceps | Olympus America, Inc. | 1996 | — |
| −1 | K962555 | Olympus FB Series Biopsy Forceps | Olympus America, Inc. | 1996 | — |
| 0 (this device) | K173760 | Monarch Endoscopy Platform (Monarch Platform) | Auris Surgical Robotics, Inc. | 2018 | — |
| +1 | K193534 | Monarch Platform | Auris Health, Inc. | 2020 | 4 |
| +2 | K211493 | Monarch Platform | Auris Health, Inc. | 2021 | 2 |
| +3 | K243219 | MONARCH™ Platform (MON-000008) | Auris Health, Inc. | 2025 | 1 |
| +2 | K203614 | Monarch Bronchoscope | Auris Health, Inc., A Johnson and Johnson Family Company | 2021 | — |
| +4 | 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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 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? (4)
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 |
|---|---|---|---|
| * | K071530 | Karl Storz Video Flexible Video Ent Endoscope SystemSummary page 5…: 21 CFR 874.4680 III. PREDICATE DEVICE(S) Trade name: Karl Storz Bronchoscope 510(k) Number: K071530 Classification Name: Bronchoscope (flexible or rigid) and accessories… | 2007 |
| * | K162611 | PeriFLEXSummary page 5…Karl Storz Endoscopy-America, Inc. Trade name: PeriFLEX Transbronchial Aspiration Needle 510(k) Number: K162611 Classification Name: Bronchoscope (flexible or rigid) and accessories… | 2017 |
| * | K962555 | Olympus FB Series Biopsy ForcepsSummary page 5…Manufacturer: Spiration, Inc. Trade name: Olympus FB series biopsy forceps 510(k) Number: K962555 Classification Name: Bronchoscope (flexible or rigid) and accessories… | 1996 |
| * | K944650 | Wang Bronchial Needle BrushSummary page 6…Page 2 of 8 Trade name: Wang Bronchial Needle Brush 510(k) Number: K944650 Classification Name: Bronchoscope (flexible or rigid) and accessories… | 1994 |
| † | K152319 | Auris Robotic Endoscopy System (ARES) | 2016 |
| † | K151376 | superDimension Navigation System | 2015 |
| † | K860582 | Tbi Needle | 1986 |
| † | K925392 | Biopsy Forceps | 1993 |
| † | K834402 | Gastrointestinal Sheath Brush | 1984 |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 19, 2019 | Class II | Z-0025-2020 | Labeling design | Reports of aspirating biopsy needle breakage |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 21.6 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K193534 (Auris Health, Inc., 2020) has gone furthest, with 5 descendants of its own.
- 4 other devices also cite its predicate K071530.
How does its category compare?
All EOQ devicesEOQ Bronchoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Endoscopy Platform (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/K173760 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173760: Monarch Endoscopy Platform (Monarch Platform).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173760
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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