510(k) · Cleared
ClearedLight Guard Light Handle and Light Handle Cover
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xodus Medical, Inc. · FTA Light, Surgical, Accessories
Cleared on Jan 19, 2006 as substantially equivalent to K911369 (Deroyal Industries, Inc., 1991) after a 50-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Jan 19, 2006
- Review
- 50 days
- Class
- Class II
- Product code
- FTA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K911369 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK911369 Qualtex Light Handle and Light Handle CoverDeroyal Industries, Inc. · 1991
- This deviceK053321 Light Guard Light Handle and Light Handle CoverXodus Medical, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K911369 | Qualtex Light Handle and Light Handle Cover | Deroyal Industries, Inc. | 1991 | — |
| 0 (this device) | K053321 | Light Guard Light Handle and Light Handle Cover | Xodus Medical, Inc. | 2006 | — |
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 |
|---|---|---|---|
| * | K911369 | Qualtex Light Handle and Light Handle CoverSummary page 1…R 878.4580 Product Code: FTA Regulatory Class: TI Predicate Device Device Name: Qualtex Light Handle Cover Common Name: Light Handle Cover 510 (k) Number: K911369 510 (k) Owner: Deroyal Industries, Inc. Classification Name: General & Plastic Surgery Regulation Number: 21 CFR 878.4800… | 1991 |
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.
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 disposable Light Handle Cover is a single use sterile product. Its intended use is as a cover for surgical light handles. It is to be placed over the light handle prior to the start of a surgical procedure to provide the nurse or surgeon with a sterile protective cover to enable them to move the light during the procedure without compromising the sterility of their hands. This product does not come in contact with the patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053321 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053321: Light Guard Light Handle and Light Handle Cover.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053321
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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