510(k) · Cleared
ClearedOutpatient Iii Minor Surgery Light
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Burton Medical Products Corp. · FSY Light, Surgical, Ceiling Mounted
Cleared on Dec 1, 2004 after a 90-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Dec 1, 2004
- Review
- 90 days
- Class
- Class II
- Product code
- FSY
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK042395 Outpatient Iii Minor Surgery LightBurton Medical Products Corp. · 2004
- Descendant · cites it directly · 1 of its ownK101537 Aim 200, Major Surgical LightBurton Medical Products Corp. · 2010
- Descendant · 2 generations on · 0 of its ownK132747 Visum Blade Led Surgical Lighting SystemStryker Communications · 2013
- Descendant · cites it directly · 0 of its ownK053364 Halux Iris Examination and Surgical LampWaldmann Lighting · 2006
Most influential descendants
Showing 3 of 3 · See all- K101537Aim 200, Major Surgical LightBurton Medical Products Corp. · 2010 · cites it directly1descendant
- K132747Visum Blade Led Surgical Lighting SystemStryker Communications · 2013 · 2 generations on0descendants
- K053364Halux Iris Examination and Surgical LampWaldmann Lighting · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042395 | Outpatient Iii Minor Surgery Light | Burton Medical Products Corp. | 2004 | — |
| +1 | K101537 | Aim 200, Major Surgical Light | Burton Medical Products Corp. | 2010 | — |
| +2 | K132747 | Visum Blade Led Surgical Lighting System | Stryker Communications | 2013 | — |
| +1 | K053364 | Halux Iris Examination and Surgical Lamp | Waldmann Lighting | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 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 FSY? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
2 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, K101537 (Burton Medical Products Corp., 2010) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FSY devicesFSY Light, Surgical, Ceiling Mounted: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FSY
7in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · FSY
59in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FSY
11in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FSY
286in 2025
MAUDE reports naming product code FSY, 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 | 3 | 29 | 0 | 70 |
| 2008 | 2 | — | 0 | 53 |
| 2009 | 2 | — | 4 | 40 |
| 2010 | 5 | 130 | 3 | 72 |
| 2011 | 0 | — | 4 | 70 |
| 2012 | 2 | — | 4 | 171 |
| 2013 | 3 | 118 | 1 | 137 |
| 2014 | 7 | 59 | 0 | 139 |
| 2015 | 0 | — | 228 | 175 |
| 2016 | 0 | — | 0 | 182 |
| 2017 | 0 | — | 0 | 162 |
| 2018 | 0 | — | 2 | 316 |
| 2019 | 0 | — | 4 | 444 |
| 2020 | 0 | — | 0 | 439 |
| 2021 | 0 | — | 0 | 380 |
| 2022 | 0 | — | 0 | 430 |
| 2023 | 0 | — | 11 | 663 |
| 2024 | 0 | — | 0 | 541 |
| 2025 | 0 | — | 0 | 286 |
| 2026 | 0 | — | 4 | — |
What is it indicated for?
The Outpatient® III Minor Surgery Light is designed to provide the required illumination for surgeries, procedures, and examinations of patients. The Outpatient®III light is to be used with various mounting configurations in operating rooms, examination rooms, emergency rooms and all other health care facilities where the need for additional illumination exists.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K042395 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042395: Outpatient Iii Minor Surgery Light.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042395
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)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026