510(k) · Cleared
ClearedBattery Powered, Disposable Endoscope Light Source
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xomed-Treace, Inc. · EQH Source, Carrier, Fiberoptic Light
Cleared on Aug 24, 1994 after a 442-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Aug 24, 1994
- Review
- 442 days
- Class
- Class I
- Product code
- EQH
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK932771 Battery Powered, Disposable Endoscope Light SourceXomed-Treace, Inc. · 1994
- Descendant · cites it directly · 7 of its ownK960081 Battery Powered Endosccopic Light SourceMitsubishi Cable America, Inc. · 1996
- Descendant · 2 generations on · 3 of its ownK042381 Coronary Sinus Visualization System, Model CSVS5508Acumen Medical, Inc. · 2004
- Descendant · 2 generations on · 2 of its ownK020889 Endoscopic Light Source XL202/L3World of Medicine Lemke GmbH · 2002
- Descendant · 3 generations on · 1 of its ownK050808 Coronary Sinus Access Kit, Model KCS8F-01Cardio-Optics, Inc. · 2005
- Descendant · 3 generations on · 1 of its ownK023468 Endoscopic Light Source XL180/L3World of Medicine Lemke GmbH · 2003
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K960081Battery Powered Endosccopic Light SourceMitsubishi Cable America, Inc. · 1996 · cites it directly7descendants
- K042381Coronary Sinus Visualization System, Model CSVS5508Acumen Medical, Inc. · 2004 · 2 generations on3descendants
- K020889Endoscopic Light Source XL202/L3World of Medicine Lemke GmbH · 2002 · 2 generations on2descendants
- K050808Coronary Sinus Access Kit, Model KCS8F-01Cardio-Optics, Inc. · 2005 · 3 generations on1descendant
- K023468Endoscopic Light Source XL180/L3World of Medicine Lemke GmbH · 2003 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K932771 | Battery Powered, Disposable Endoscope Light Source | Xomed-Treace, Inc. | 1994 | — |
| +1 | K960081 | Battery Powered Endosccopic Light Source | Mitsubishi Cable America, Inc. | 1996 | — |
| +2 | K042381 | Coronary Sinus Visualization System, Model CSVS5508 | Acumen Medical, Inc. | 2004 | — |
| +2 | K020889 | Endoscopic Light Source XL202/L3 | World of Medicine Lemke GmbH | 2002 | — |
| +3 | K050808 | Coronary Sinus Access Kit, Model KCS8F-01 | Cardio-Optics, Inc. | 2005 | — |
| +3 | K023468 | Endoscopic Light Source XL180/L3 | World of Medicine Lemke GmbH | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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 EQH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K960081 | Battery Powered Endosccopic Light Source | 1996 | 7 |
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, K960081 (Mitsubishi Cable America, Inc., 1996) has gone furthest, with 7 descendants of its own.
How does its category compare?
All EQH devicesEQH Source, Carrier, Fiberoptic Light: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EQH
FDA has decided no EQH device since 2007.
Median 510(k) review, days · EQH
Too few EQH 510(k)s in any year since 2007 to give a median.
Recalls per year · EQH
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EQH
2in 2024
MAUDE reports naming product code EQH, 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 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K932771 · printed Nov 4, 2026
Cite this page
510(k) Report. “K932771: Battery Powered, Disposable Endoscope Light Source.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K932771
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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