510(k) · Cleared
ClearedBattery Powered Endosccopic Light Source
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mitsubishi Cable America, Inc. · FCQ Light Source, Incandescent, Diagnostic
Cleared on Mar 12, 1996 as substantially equivalent to K932771 (Xomed-Treace, Inc., 1994) after a 61-day review. Its family tree reaches back 1 generation to 1994. 7 later devices descend from it.
- Decided
- Mar 12, 1996
- Review
- 61 days
- Class
- Class II
- Product code
- FCQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K932771 (1994). 7 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK932771 Battery Powered, Disposable Endoscope Light SourceXomed-Treace, Inc. · 1994
- This deviceK960081 Battery Powered Endosccopic Light SourceMitsubishi Cable America, Inc. · 1996
- Descendant · cites it directly · 3 of its ownK042381 Coronary Sinus Visualization System, Model CSVS5508Acumen Medical, Inc. · 2004
- Descendant · cites it directly · 2 of its ownK020889 Endoscopic Light Source XL202/L3World of Medicine Lemke GmbH · 2002
- Descendant · 2 generations on · 1 of its ownK050808 Coronary Sinus Access Kit, Model KCS8F-01Cardio-Optics, Inc. · 2005
- Descendant · 2 generations on · 1 of its ownK023468 Endoscopic Light Source XL180/L3World of Medicine Lemke GmbH · 2003
- Descendant · 2 generations on · 0 of its ownK070051 Acumen Insight Endocardial Visualization SystemAcumen Medical, Inc. · 2007
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K042381Coronary Sinus Visualization System, Model CSVS5508Acumen Medical, Inc. · 2004 · cites it directly3descendants
- K020889Endoscopic Light Source XL202/L3World of Medicine Lemke GmbH · 2002 · cites it directly2descendants
- K050808Coronary Sinus Access Kit, Model KCS8F-01Cardio-Optics, Inc. · 2005 · 2 generations on1descendant
- K023468Endoscopic Light Source XL180/L3World of Medicine Lemke GmbH · 2003 · 2 generations on1descendant
- K070051Acumen Insight Endocardial Visualization SystemAcumen Medical, Inc. · 2007 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932771 | Battery Powered, Disposable Endoscope Light Source | Xomed-Treace, Inc. | 1994 | — |
| 0 (this device) | K960081 | Battery Powered Endosccopic Light Source | Mitsubishi Cable America, Inc. | 1996 | — |
| +1 | K042381 | Coronary Sinus Visualization System, Model CSVS5508 | Acumen Medical, Inc. | 2004 | — |
| +1 | K020889 | Endoscopic Light Source XL202/L3 | World of Medicine Lemke GmbH | 2002 | — |
| +2 | K050808 | Coronary Sinus Access Kit, Model KCS8F-01 | Cardio-Optics, Inc. | 2005 | — |
| +2 | K023468 | Endoscopic Light Source XL180/L3 | World of Medicine Lemke GmbH | 2003 | — |
| +2 | K070051 | Acumen Insight Endocardial Visualization System | Acumen Medical, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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 FCQ? 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? (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 |
|---|---|---|---|
| * | K932771 | Battery Powered, Disposable Endoscope Light SourceSummary page 1…lent to the “Xomed-Treace E-Luminator™ II Battery Powered Disposable Endoscope Light Source” that was approved by FDA for marketing on August 24, 1994, under 510(k) No. K932771. 4) Description of Device: The Mitsubishi Battery Powered Endoscopic Light Source is a lightweight, portable, battery powered l… | 1994 |
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K042381 (Acumen Medical, Inc., 2004) has gone furthest, with 3 descendants of its own.
How does its category compare?
All FCQ devicesFCQ Light Source, Incandescent, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FCQ
FDA has decided no FCQ device since 2007.
Median 510(k) review, days · FCQ
Too few FCQ 510(k)s in any year since 2007 to give a median.
Recalls per year · FCQ
No recall names FCQ since 2007.
Adverse event reports per year · FCQ
1in 2025
MAUDE reports naming product code FCQ, 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 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 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 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Mitsubishi Battery Powered Endoscopic Light Source is intended for use as a light source for diagnostic endoscopes.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K960081 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960081: Battery Powered Endosccopic Light Source.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960081
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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