510(k) · Cleared
ClearedOperating Room Light Handle Adapter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Litex Manufacturing, Inc. · FTA Light, Surgical, Accessories
Cleared on Sep 29, 2014 as substantially equivalent to K915068 (American Medical Mfg., Inc., 1992) after a 33-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Sep 29, 2014
- Review
- 33 days
- Class
- Class II
- Product code
- FTA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K915068 (1992). No later device cites it as a predicate yet.
- Root · 1 generation backK915068 Plastic Disposable Surgical Light Handle CoverAmerican Medical Mfg., Inc. · 1992
- This deviceK142386 Operating Room Light Handle AdapterLitex Manufacturing, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915068 | Plastic Disposable Surgical Light Handle Cover | American Medical Mfg., Inc. | 1992 | — |
| 0 (this device) | K142386 | Operating Room Light Handle Adapter | Litex Manufacturing, Inc. | 2014 | — |
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 FTA? 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 |
|---|---|---|---|
| * | K915068 | Plastic Disposable Surgical Light Handle CoverSummary page 4…Predicate Device 510(k) Comparison Number Litex American Medical K915068 The subject device is Manufacturing, Inc. MFG., Inc. Plastic basically identical to the Lig… | 1992 |
What descends from it?
No later submission names this one as a predicate yet.
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.
How does its category compare?
All FTA devicesFTA Light, Surgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · FTA
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · FTA
61in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTA
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTA
19in 2025
MAUDE reports naming product code FTA, 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 | — | 2 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 18 |
| 2014 | 3 | 61 | 0 | 7 |
| 2015 | 1 | — | 0 | 15 |
| 2016 | 0 | — | 0 | 15 |
| 2017 | 0 | — | 1 | 22 |
| 2018 | 0 | — | 0 | 21 |
| 2019 | 0 | — | 0 | 20 |
| 2020 | 0 | — | 0 | 18 |
| 2021 | 0 | — | 0 | 20 |
| 2022 | 0 | — | 0 | 14 |
| 2023 | 0 | — | 0 | 105 |
| 2024 | 0 | — | 0 | 29 |
| 2025 | 0 | — | 0 | 19 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The Light Handle Adapters are permanent replacements to the original OEM handle provided by the light manufacturer in the event that the customer wishes to use a disposable light handle cover. This will eliminate the cleaning and re-sterilizing of the original OEM reusable light handle. The customer will need to replace the original OEM handle, with the light handle adapter that Litex Manufacturing, Inc. will provide the facility, through the light companies and other distributors.
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/K142386 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142386: Operating Room Light Handle Adapter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142386
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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