510(k) · Cleared
Recalled · Class II · 2025Galaxy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Noah Medical Corp. · EOQ Bronchoscope (Flexible Or Rigid)
Cleared on Mar 1, 2023 as substantially equivalent to K173760 (Auris Surgical Robotics, Inc., 2018) after a 148-day review. Its family tree reaches back 3 generations to 1996. It has been recalled 5 times.
- Decided
- Mar 1, 2023
- Review
- 148 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 3 generations to K955065 (1996). 7 ancestors in all, the oldest K914181 (1991). No later device cites it as a predicate yet.
- Root · 3 generations backK955065 Olympus FB Series Biopsy ForcepsOlympus America, Inc. · 1996
- 2 generations backK962555 Olympus FB Series Biopsy ForcepsOlympus America, Inc. · 1996
- 1 generation backK173760 Monarch Endoscopy Platform (Monarch Platform)Auris Surgical Robotics, Inc. · 2018 · Recalled
- This deviceK223144 Galaxy SystemNoah Medical Corp. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K955065 | Olympus FB Series Biopsy Forceps | Olympus America, Inc. | 1996 | — |
| −2 | K962555 | Olympus FB Series Biopsy Forceps | Olympus America, Inc. | 1996 | — |
| −1 | K173760 | Monarch Endoscopy Platform (Monarch Platform) | Auris Surgical Robotics, Inc. | 2018 | 1 |
| 0 (this device) | K223144 | Galaxy System | Noah Medical Corp. | 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 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 |
|---|---|---|---|
| * | K173760 | Monarch Endoscopy Platform (Monarch Platform)Summary page 4…cessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures. Primary Predicate Device: • K173760, Auris Surgical, Monarch Endoscopy Platform Reference Device: • K173244, Covidien, Super Dimension Navigation System… | 2018 |
| † | K173244 | superDimension Navigation System V7.2 | 2018 |
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 |
|---|---|---|---|---|
| Sep 12, 2025 | Class II | Z-0598-2026 | Under Investigation by firm | Due to Users not having access to the Instructions for Use/User Manual due to it being password protected. |
| Oct 28, 2024 | Class II | Z-0742-2025 | Component change control | Bronchoscopic visualization system power supplies have defective semiconductor components that may fail unexpectedly, which could result in an aborted procedure since it is a non recoverable failure. Manual removal of the bronchoscope… |
| Oct 25, 2024 | Class II | Z-0679-2025 | Device Design | Not all biopsy tools meant to fit bronchoscope channel (2.1mm inner diameter/length greater or equal to 1100mm) will pass through if scope channel positioned in sharp bend (approx. greater than 100-deg.), excessive force may result in… |
| Oct 25, 2024 | Class II | Z-0693-2025 | Device Design | Bronchoscopic system uninterruptable power may have defective component, may cause power supply short circuit/trip protective circuit breakers causing sudden, unrecoverable power loss, which could occur while system is on mains or… |
| Mar 9, 2024 | Class II | Z-1734-2024 | Process control | Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- 2 of the 7 ancestors have a recall of any class.
- 1 other device also cites its predicate K173760.
How does its category compare?
All EOQ devicesEOQ Bronchoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Galaxy System 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/K223144 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223144: Galaxy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223144
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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