510(k) · Cleared
ClearedIntegra Led Surgical Headlight System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra LifeSciences Corporation · FSR Light, Headband, Surgical
Cleared on May 11, 2011 as substantially equivalent to K031548 (Welch Allyn, Inc., 2003) after a 76-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- May 11, 2011
- Review
- 76 days
- Class
- Class II
- Product code
- FSR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K031548 (2003). No later device cites it as a predicate yet.
- Root · 1 generation backK031548 Led HeadlightWelch Allyn, Inc. · 2003
- This deviceK110528 Integra Led Surgical Headlight SystemIntegra LifeSciences Corporation · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K031548 | Led Headlight | Welch Allyn, Inc. | 2003 | — |
| 0 (this device) | K110528 | Integra Led Surgical Headlight System | Integra LifeSciences Corporation | 2011 | — |
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 |
|---|---|---|---|
| * | K031548 | Led HeadlightSummary page 1…urgical Device Class: Class 11 Product Code: FSR CFR Classification: 21 CFR 886.4335 Predicate Device: 5 10(k) #K031548 Welch Allyn's Solid State Procedure Headlight Device Description: The Integra Tm LED Surgical Head… | 2003 |
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 FSR devicesFSR Light, Headband, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 Integra Tm LED Surgical Headlight System is designed to provide illumination to aid visualization during minor surgical, diagnostic, or therapeutic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110528 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110528: Integra Led Surgical Headlight System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110528
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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