510(k) · Cleared
ClearedChromalume Turbo Light Source with Xtremebeam Fiber Optic Headlampfst Model FST
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bfw, Inc. · FST Light, Surgical, Fiberoptic
Cleared on Jan 28, 2010 as substantially equivalent to K071218 (Welch Allyn, Inc., 2007) after a 90-day review. Its family tree reaches back 2 generations to 1999.
- Decided
- Jan 28, 2010
- Review
- 90 days
- Class
- Class II
- Product code
- FST
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K991572 (1999). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 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? (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 |
|---|---|---|---|
| * | K071218 | Proxenon 350, Model 902XXSummary page 1…40206 Common or Usual Name Surgical Lamp Classification Name Lamp, Surgical Fiberoptic Predicate Device Welch Allyn, Inc. Model ProXenon 350 Surgical Illuminator (K071218). Intended Use The ChromiaLUME Turbo Light Source is designed for use with fiber optic headlight systems to supply high intensi… | 2007 |
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?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 7.9 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All FST devicesFST Light, Surgical, Fiberoptic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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 ChromaLUME Turbo Light Source is designed for use with fiber optic headlight systems to supply high intensity light through the fiber optic cable for illumination of a surgical field. The ChromaLUME Turbo Light Source will accommodate fiber optic cables from Wolf, Storz, Olympus and ACMI/BFW products.
The XtremeBeam Fiber Optic Headlamp is a passive luminary which is illuminated by the fiber optic light to provide supplemental light for surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093386 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093386: Chromalume Turbo Light Source with Xtremebeam Fiber Optic Headlampfst Model FST.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093386
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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