510(k) · Cleared
Recalled · Class II · 2012M3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mavig GmbH · FSY Light, Surgical, Ceiling Mounted
Cleared on Nov 21, 2006 as substantially equivalent to K024132 (Berchtold Holding GmbH, 2003) after a 15-day review. Its family tree reaches back 2 generations to 1997. It has been recalled once.
- Decided
- Nov 21, 2006
- Review
- 15 days
- Class
- Class II
- Product code
- FSY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K965130 (1997). 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 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? (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 |
|---|---|---|---|
| * | K024132 | Chromophare X 65Summary page 2…xamination and surgical site on the patient in the clinic and doctor's office. Predicate Device Chromophare X65, K024132. Substantial Equivalence: The M3 is substantially equivalent to the surgical light CHROMOPHARE… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 10, 2012 | Class II | Z-0515-2013 | Equipment maintenance | A particular component may not have been fitted during the installation of some MAVIG PORTEGRA 2 systems. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 5.7 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K024132.
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 surgical light M3 is intended to illuminate locally the operating site on the patient's body with a high intensity, shadow-free, "cold' light.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063333 · printed Nov 3, 2026
Cite this page
510(k) Report. “K063333: M3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K063333
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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