510(k) · Cleared
ClearedWang Bronchial Needle Brush
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mill-Rose Laboratory · EOQ Bronchoscope (Flexible Or Rigid)
Cleared on Nov 22, 1994 after a 62-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 9 later devices descend from it.
- Decided
- Nov 22, 1994
- Review
- 62 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 2 citing it directly.
- This deviceK944650 Wang Bronchial Needle BrushMill-Rose Laboratory · 1994
- Descendant · cites it directly · 7 of its ownK173760 Monarch Endoscopy Platform (Monarch Platform)Auris Surgical Robotics, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 5 of its ownK193534 Monarch PlatformAuris Health, Inc. · 2020 · Recalled
- Descendant · 3 generations on · 2 of its ownK211493 Monarch PlatformAuris Health, Inc. · 2021 · Recalled
- Descendant · 4 generations on · 1 of its ownK243219 MONARCH™ Platform (MON-000008)Auris Health, Inc. · 2025 · Recalled
- Descendant · 3 generations on · 1 of its ownK203614 Monarch BronchoscopeAuris Health, Inc., A Johnson and Johnson Family Company · 2021
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K173760Monarch Endoscopy Platform (Monarch Platform)Auris Surgical Robotics, Inc. · 2018 · cites it directly7descendants
- K193534Monarch PlatformAuris Health, Inc. · 2020 · 2 generations on5descendants
- K211493Monarch PlatformAuris Health, Inc. · 2021 · 3 generations on2descendants
- K243219MONARCH™ Platform (MON-000008)Auris Health, Inc. · 2025 · 4 generations on1descendant
- K203614Monarch BronchoscopeAuris Health, Inc., A Johnson and Johnson Family Company · 2021 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K944650 | Wang Bronchial Needle Brush | Mill-Rose Laboratory | 1994 | — |
| +1 | K173760 | Monarch Endoscopy Platform (Monarch Platform) | Auris Surgical Robotics, Inc. | 2018 | 1 |
| +2 | K193534 | Monarch Platform | Auris Health, Inc. | 2020 | 4 |
| +3 | K211493 | Monarch Platform | Auris Health, Inc. | 2021 | 2 |
| +4 | K243219 | MONARCH™ Platform (MON-000008) | Auris Health, Inc. | 2025 | 1 |
| +3 | K203614 | Monarch Bronchoscope | Auris Health, Inc., A Johnson and Johnson Family Company | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (9)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K173760 (Auris Surgical Robotics, Inc., 2018) has gone furthest, with 7 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.
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 | — |
https://510kreport.com/device/K944650 · printed Nov 6, 2026
Cite this page
510(k) Report. “K944650: Wang Bronchial Needle Brush.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K944650
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026