510(k) · Cleared
ClearedIsolux Surgical Headlight
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Isolux America · FST Light, Surgical, Fiberoptic
Cleared on Jul 8, 1999 after a 64-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Jul 8, 1999
- Review
- 64 days
- Class
- Class II
- Product code
- FST
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK991572 Isolux Surgical HeadlightIsolux America · 1999
- Descendant · cites it directly · 1 of its ownK071218 Proxenon 350, Model 902XXWelch Allyn, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK093386 Chromalume Turbo Light Source with Xtremebeam Fiber Optic…Bfw, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK061622 PS SeriesPhotonic Optische Gerate Gesmbh & Cokg · 2007
- Descendant · cites it directly · 0 of its ownK070287 PS Series with Fiber Light Guide and Headlight, Models PS200, PS250…Photonic Optische Gerate GmbH & Cokg · 2007
Most influential descendants
Showing 4 of 4 · See all- K071218Proxenon 350, Model 902XXWelch Allyn, Inc. · 2007 · cites it directly1descendant
- K093386Chromalume Turbo Light Source with Xtremebeam Fiber Optic Headlampfst Model FSTBfw, Inc. · 2010 · 2 generations on0descendants
- K061622PS SeriesPhotonic Optische Gerate Gesmbh & Cokg · 2007 · cites it directly0descendants
- K070287PS Series with Fiber Light Guide and Headlight, Models PS200, PS250, PS500Photonic Optische Gerate GmbH & Cokg · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991572 | Isolux Surgical Headlight | Isolux America | 1999 | — |
| +1 | K071218 | Proxenon 350, Model 902XX | Welch Allyn, Inc. | 2007 | — |
| +2 | K093386 | Chromalume Turbo Light Source with Xtremebeam Fiber Optic Headlampfst Model FST | Bfw, Inc. | 2010 | — |
| +1 | K061622 | PS Series | Photonic Optische Gerate Gesmbh & Cokg | 2007 | — |
| +1 | K070287 | PS Series with Fiber Light Guide and Headlight, Models PS200, PS250, PS500 | Photonic Optische Gerate GmbH & Cokg | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 3 | 0 |
| 2010 | 1 | 0 |
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? (4)
3 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?
- Of its descendants, K071218 (Welch Allyn, Inc., 2007) has gone furthest, with 1 descendant of its own.
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 ISOLUX America's Surgical Headlight is indicated for
illumination purposes from an illuminator to a headlight to
aid in providing illumination to body cavities during
examinations or surgical procedures,
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991572 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991572: Isolux Surgical Headlight.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991572
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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