510(k) · Cleared
Recalled · Class II · 2015ILED
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg · FSY Light, Surgical, Ceiling Mounted
Cleared on Jun 22, 2006 as substantially equivalent to K024132 (Berchtold Holding GmbH, 2003) after a 42-day review. Its family tree reaches back 2 generations to 1997. 16 later devices descend from it. It has been recalled 7 times.
- Decided
- Jun 22, 2006
- Review
- 42 days
- Class
- Class II
- Product code
- FSY
- Recalls
- 7
- Predicates
- 1
Its longest line of descent runs back 2 generations to K965130 (1997). 16 later devices descend from it, 7 citing it directly.
- Root · 2 generations backK965130 ChromophareBerchtold Holding GmbH · 1997
- 1 generation backK024132 Chromophare X 65Berchtold Holding GmbH · 2003
- This deviceK061317 ILEDTrumpf Kreuzer Medizin Systeme GmbH + Co.Kg · 2006
- Descendant · cites it directly · 10 of its ownK072072 Harmony Led-1 Surgical Lighting SystemSTERIS Corporation · 2007 · Recalled
- Descendant · 2 generations on · 4 of its ownK093009 Mach Led SCDr. Mach GmbH & Co. KG · 2010
- Descendant · cites it directly · 2 of its ownK093010 Mach Led MCDr. Mach GmbH & Co. KG · 2010
- Descendant · 3 generations on · 1 of its ownK132307 Vida Led Surgical Lighting SystemConvida Healthcare & Systems Corporation · 2013
- Descendant · cites it directly · 1 of its ownK100388 21ST Century Centurion Exceled and System Two Led Lighting SystemsMedical Illumination International, Inc. · 2010
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K072072Harmony Led-1 Surgical Lighting SystemSTERIS Corporation · 2007 · cites it directly10descendants
- K093009Mach Led SCDr. Mach GmbH & Co. KG · 2010 · 2 generations on4descendants
- K093010Mach Led MCDr. Mach GmbH & Co. KG · 2010 · cites it directly2descendants
- K132307Vida Led Surgical Lighting SystemConvida Healthcare & Systems Corporation · 2013 · 3 generations on1descendant
- K10038821ST Century Centurion Exceled and System Two Led Lighting SystemsMedical Illumination International, Inc. · 2010 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K965130 | Chromophare | Berchtold Holding GmbH | 1997 | — |
| −1 | K024132 | Chromophare X 65 | Berchtold Holding GmbH | 2003 | — |
| 0 (this device) | K061317 | ILED | Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg | 2006 | — |
| +1 | K072072 | Harmony Led-1 Surgical Lighting System | STERIS Corporation | 2007 | 1 |
| +2 | K093009 | Mach Led SC | Dr. Mach GmbH & Co. KG | 2010 | — |
| +1 | K093010 | Mach Led MC | Dr. Mach GmbH & Co. KG | 2010 | — |
| +3 | K132307 | Vida Led Surgical Lighting System | Convida Healthcare & Systems Corporation | 2013 | — |
| +1 | K100388 | 21ST Century Centurion Exceled and System Two Led Lighting Systems | Medical Illumination International, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 5 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 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 |
|---|---|---|---|
| * | K024132 | Chromophare X 65Summary page 2…site on the patient's body with a high intensity, shadow fee, "cold" light, Predicate Device: CHROMOPHARE X 65 K#024132 Substantial Equivalence: The LED is substantially equivalent to the surgical light CHROMOPHARE X65.… | 2003 |
What descends from it? (16)
See all 167 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072072 | Harmony Led-1 Surgical Lighting System | 2007 | 10 |
| K093010 | Mach Led MC | 2010 | 2 |
| K100388 | 21ST Century Centurion Exceled and System Two Led Lighting Systems | 2010 | 1 |
| K123776 | Polaris 100/200 | 2013 | 0 |
| K102758 | Trulight 5520 and Trulight 5320 | 2010 | 0 |
| K091246 | Iled 3 Mobile (I300M), Trulight 5500 Mobile (T500M), Trulight 5300 Mobile (T300M) | 2009 | 0 |
| K083323 | Nuvo Verde Led Lighting System | 2009 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 2, 2015 | Class II | Z-0563-2016 | Other | The firm has received 15 complaints over ten years related to the connection of the spring arm to the top horizontal arm of the lighting system that while positioning the light head enabled the spring arm and light head to fall. |
| Jul 27, 2015 | Class II | Z-2353-2015 | Process control | Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor. |
| Jul 27, 2015 | Class II | Z-2354-2015 | Process control | Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor. |
| Jul 27, 2015 | Class II | Z-2356-2015 | Process control | Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor. |
| Jul 27, 2015 | Class II | Z-2357-2015 | Process control | Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor. |
| May 29, 2012 | Class II | Z-2311-2012 | Process control | Cracks can arise on the welded seam on the rear joint. |
| Feb 27, 2009 | Not classified | Z-1122-2009 | Other | Cracks may form around the screw connections of the cover plates causing brittleness, which may lead to fragments breaking off and falling into the operating area. |
The 5 latest of 7 recalls; the web page lists all.
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.
- Of its descendants, K072072 (STERIS Corporation, 2007) has gone furthest, with 10 descendants of its own.
- 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 iLED is intended to illuminate locally the operating site on the patient's body with a high intensity, shadow fee, "cold" light,
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061317 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061317: ILED.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061317
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