510(k) · Cleared
ClearedLed Headlight
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Welch Allyn, Inc. · FSR Light, Headband, Surgical
Cleared on Aug 11, 2003 after an 87-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Aug 11, 2003
- Review
- 87 days
- Class
- Class II
- Product code
- FSR
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK031548 Led HeadlightWelch Allyn, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK110528 Integra Led Surgical Headlight SystemIntegra LifeSciences Corporation · 2011
Most influential descendants
Showing 1 of 1 · See all- K110528Integra Led Surgical Headlight SystemIntegra LifeSciences Corporation · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031548 | Led Headlight | Welch Allyn, Inc. | 2003 | — |
| +1 | K110528 | Integra Led Surgical Headlight System | Integra LifeSciences Corporation | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
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 FSR? 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 |
|---|---|---|---|
| * | — | Halogen Headlight Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110528 | Integra Led Surgical Headlight System | 2011 | 0 |
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, K110528 (Integra LifeSciences Corporation, 2011) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FSR devicesFSR Light, Headband, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FSR
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · FSR
Too few FSR 510(k)s in any year since 2007 to give a median.
Recalls per year · FSR
No recall names FSR since 2007.
Adverse event reports per year · FSR
10in 2025
MAUDE reports naming product code FSR, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 13 |
| 2021 | 0 | — | 0 | 14 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 0 | 11 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Solid State Procedure Headlight is indicated for providing illumination to aid visualization during minor surgical, diagnostic, or therapeutic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031548 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031548: Led Headlight.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031548
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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