510(k) · Cleared
ClearedIled 3 Mobile (I300M), Trulight 5500 Mobile (T500M), Trulight 5300 Mobile (T300M)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trumpf Medizin Systeme GmbH + Co. KG · FSS Light, Surgical, Floor Standing
Cleared on Sep 28, 2009 as substantially equivalent to K061317 (Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg, 2006) and 1 other predicate after a 154-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Sep 28, 2009
- Review
- 154 days
- Class
- Class II
- Product code
- FSS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K965130 (1997). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK965130 ChromophareBerchtold Holding GmbH · 1997
- 2 generations backK024132 Chromophare X 65Berchtold Holding GmbH · 2003
- 1 generation backK061317 ILEDTrumpf Kreuzer Medizin Systeme GmbH + Co.Kg · 2006 · Recalled
- This deviceK091246 Iled 3 Mobile (I300M), Trulight 5500 Mobile (T500M), Trulight 5300…Trumpf Medizin Systeme GmbH + Co. KG · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K965130 | Chromophare | Berchtold Holding GmbH | 1997 | — |
| −2 | K024132 | Chromophare X 65 | Berchtold Holding GmbH | 2003 | — |
| −1 | K061317 | ILED | Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg | 2006 | 7 |
| 0 (this device) | K091246 | Iled 3 Mobile (I300M), Trulight 5500 Mobile (T500M), Trulight 5300 Mobile… | Trumpf Medizin Systeme GmbH + Co. KG | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 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 FSS? 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? (2)
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 |
|---|---|---|---|
| * | K061317 | ILEDSummary page 2…the surgical site with a high intensity, homogenous light. Predicate Device: iLED (lamp heads are identical) K# 061317 Trumpf surgical light models 301, 501, 701, and 1001 --(mobile stand option wa… | 2006 |
| * | K011693 | Trumpf Surgical Lights, Models 301,501,701,1001Summary page 2…Trumpf surgical light models 301, 501, 701, and 1001 --(mobile stand option was included) K # 011693 Substantial Equivalence: The iLED surgical light mobile family had identical lamp heads as the iLED sur… | 2001 |
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?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- 2 of the 5 ancestors have a recall of any class.
- 6 other devices also cite its predicate K061317.
How does its category compare?
All FSS devicesFSS Light, Surgical, Floor Standing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · FSS
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · FSS
Too few FSS 510(k)s in any year since 2007 to give a median.
Recalls per year · FSS
No recall names FSS since 2007.
Adverse event reports per year · FSS
3in 2025
MAUDE reports naming product code FSS, 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 | 1 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 11 |
| 2014 | 0 | — | 0 | 14 |
| 2015 | 0 | — | 0 | 10 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 13 |
| 2020 | 0 | — | 0 | 9 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 15 |
| 2024 | 0 | — | 0 | 11 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The surgical light family 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/K091246 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091246: Iled 3 Mobile (I300M), Trulight 5500 Mobile (T500M), Trulight 5300 Mobile (T300M).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091246
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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