510(k) · Cleared
Recalled · 2011Surgical Headlight
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gulf Medical Fiberoptics · FST Light, Surgical, Fiberoptic
Cleared on Sep 15, 2006 after a 92-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled once.
- Decided
- Sep 15, 2006
- Review
- 92 days
- Class
- Class II
- Product code
- FST
- Recalls
- 1
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FST? 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 FST device
- #1 K200874 TruView Light Cable, TruView Lateral Retractor…score -0.4 · 1 generation · no Class I recall
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|---|
| May 13, 2011 | Not classified | Z-0831-2012 | Process control | Gulf Medical Fiberoptics, Inc. recalled their Surgical Headlight because the cleaning instructions for the exterior surfaces of the headlight , headgear and fiber cable with 70% isopropyl alcohol had not been validated. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All FST devicesFST Light, Surgical, Fiberoptic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FST
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · FST
59in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FST
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FST
27in 2025
MAUDE reports naming product code FST, 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 | 1 | — | 0 | 3 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 3 | 100 | 0 | 4 |
| 2010 | 5 | 90 | 0 | 3 |
| 2011 | 0 | — | 10 | 7 |
| 2012 | 3 | 59 | 0 | 14 |
| 2013 | 0 | — | 0 | 9 |
| 2014 | 1 | — | 1 | 13 |
| 2015 | 0 | — | 0 | 14 |
| 2016 | 0 | — | 0 | 15 |
| 2017 | 0 | — | 0 | 20 |
| 2018 | 0 | — | 0 | 12 |
| 2019 | 0 | — | 0 | 29 |
| 2020 | 1 | — | 0 | 33 |
| 2021 | 0 | — | 0 | 20 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 0 | 11 |
| 2024 | 0 | — | 0 | 40 |
| 2025 | 0 | — | 0 | 27 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The use for this particular device is to be worn on the surgeons head and to illuminate the body cavity during examinations or surgical procedures. This product is shipped to the end user non-sterile.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K061690 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061690: Surgical Headlight.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061690
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026