510(k) · Cleared
Recalled · Class II · 2015Trumpf Surgical Lights, Models 301,501,701,1001
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trumpf Medical Systems, Inc. · FSY Light, Surgical, Ceiling Mounted
Cleared on Jun 13, 2001 as substantially equivalent to K984611 (Drager Medizintechnik GmbH, 1999) after a 13-day review. Its family tree reaches back 1 generation to 1999. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- Jun 13, 2001
- Review
- 13 days
- Class
- Class II
- Product code
- FSY
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K984611 (1999). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK984611 Drager Sola Series, Models 1000/700/500/300Drager Medizintechnik GmbH · 1999
- This deviceK011693 Trumpf Surgical Lights, Models 301,501,701,1001Trumpf Medical Systems, Inc. · 2001
- Descendant · cites it directly · 0 of its ownK102758 Trulight 5520 and Trulight 5320Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg · 2010 · Recalled
- Descendant · cites it directly · 0 of its ownK091246 Iled 3 Mobile (I300M), Trulight 5500 Mobile (T500M), Trulight 5300…Trumpf Medizin Systeme GmbH + Co. KG · 2009
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K984611 | Drager Sola Series, Models 1000/700/500/300 | Drager Medizintechnik GmbH | 1999 | — |
| 0 (this device) | K011693 | Trumpf Surgical Lights, Models 301,501,701,1001 | Trumpf Medical Systems, Inc. | 2001 | — |
| +1 | K102758 | Trulight 5520 and Trulight 5320 | Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg | 2010 | 2 |
| +1 | K091246 | Iled 3 Mobile (I300M), Trulight 5500 Mobile (T500M), Trulight 5300 Mobile… | Trumpf Medizin Systeme GmbH + Co. KG | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 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 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 |
|---|---|---|---|
| * | K984611 | Drager Sola Series, Models 1000/700/500/300Summary page 1…tion Light Classification: 21 CFR 878.4580 — Surgical Light — Class II Product Code FSY Drager Sola Surgical Light legally marketed under 510(k) premarket notification K984611. The Trumpf surgical lights are intended to locally illuminate an operating or examination area of the patient’s body with high… | 1999 |
What descends from it? (2)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 27, 2015 | Class II | Z-2355-2015 | Process control | Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor. |
| Feb 19, 2013 | Class II | Z-0484-2014 | Nonconforming Material/Component | Possible fatigue failure of the plastic joint may occur after an average use of seven years. |
| Sep 19, 2012 | Class II | Z-0077-2013 | Device Design | Incidents regarding fractures of the front joint of the spring arm have been reported. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K102758 (Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg, 2010) has gone furthest, with 0 descendants 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 Trumpf surgical lights are intended to locally illuminate an operating or examination area of the patient’s body with high intensity light.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011693 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011693: Trumpf Surgical Lights, Models 301,501,701,1001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011693
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026