510(k) · Cleared
ClearedDrager Sola Series, Models 1000/700/500/300
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Drager Medizintechnik GmbH · FSY Light, Surgical, Ceiling Mounted
Cleared on Mar 29, 1999 after a 90-day review. The FDA summary names no predicate by number. 3 later devices descend from it.
- Decided
- Mar 29, 1999
- Review
- 90 days
- Class
- Class II
- Product code
- FSY
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK984611 Drager Sola Series, Models 1000/700/500/300Drager Medizintechnik GmbH · 1999
- Descendant · cites it directly · 2 of its ownK011693 Trumpf Surgical Lights, Models 301,501,701,1001Trumpf Medical Systems, Inc. · 2001 · Recalled
- Descendant · 2 generations on · 0 of its ownK102758 Trulight 5520 and Trulight 5320Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg · 2010 · Recalled
- Descendant · 2 generations on · 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 3 of 3 · See all- K011693Trumpf Surgical Lights, Models 301,501,701,1001Trumpf Medical Systems, Inc. · 2001 · cites it directly2descendants
- K102758Trulight 5520 and Trulight 5320Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg · 2010 · 2 generations on0descendants
- K091246Iled 3 Mobile (I300M), Trulight 5500 Mobile (T500M), Trulight 5300 Mobile (T300M)Trumpf Medizin Systeme GmbH + Co. KG · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K984611 | Drager Sola Series, Models 1000/700/500/300 | Drager Medizintechnik GmbH | 1999 | — |
| +1 | K011693 | Trumpf Surgical Lights, Models 301,501,701,1001 | Trumpf Medical Systems, Inc. | 2001 | 3 |
| +2 | K102758 | Trulight 5520 and Trulight 5320 | Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg | 2010 | 2 |
| +2 | 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 |
|---|---|---|
| 2001 | 1 | 0 |
| 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?
The FDA summary names no predicate by number.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K011693 | Trumpf Surgical Lights, Models 301,501,701,1001 | 2001 | 2 |
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, K011693 (Trumpf Medical Systems, Inc., 2001) has gone furthest, with 2 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 Driiger Sola surgical lights (Sola 1000, 700, 500) are intended to locally illuminate an operating or examination area of the patient’s body with high intensity light.
The Dréiger Sola 300 is intended to be used as an examination light or as a satellite light within a surgical lighting system.
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/K984611 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984611: Drager Sola Series, Models 1000/700/500/300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984611
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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