510(k) · Cleared
Recalled · Class II · 2014Harmony Vled Surgical Lightning System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
STERIS Corporation · FST Light, Surgical, Fiberoptic
Cleared on Mar 17, 2010 as substantially equivalent to K072072 (STERIS Corporation, 2007) after a 29-day review. Its family tree reaches back 4 generations to 1997. It has been recalled once.
- Decided
- Mar 17, 2010
- Review
- 29 days
- Class
- Class II
- Product code
- FST
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K965130 (1997). 8 ancestors in all, the oldest K904965 (1991). No later device cites it as a predicate yet.
- Root · 4 generations backK965130 ChromophareBerchtold Holding GmbH · 1997
- 3 generations backK024132 Chromophare X 65Berchtold Holding GmbH · 2003
- 2 generations backK061317 ILEDTrumpf Kreuzer Medizin Systeme GmbH + Co.Kg · 2006 · Recalled
- 1 generation backK072072 Harmony Led-1 Surgical Lighting SystemSTERIS Corporation · 2007 · Recalled
- This deviceK100395 Harmony Vled Surgical Lightning SystemSTERIS Corporation · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K965130 | Chromophare | Berchtold Holding GmbH | 1997 | — |
| −3 | K024132 | Chromophare X 65 | Berchtold Holding GmbH | 2003 | — |
| −2 | K061317 | ILED | Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg | 2006 | 7 |
| −1 | K072072 | Harmony Led-1 Surgical Lighting System | STERIS Corporation | 2007 | 1 |
| 0 (this device) | K100395 | Harmony Vled Surgical Lightning System | STERIS Corporation | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 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 FST? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FST device
- #1 K200874 TruView Light Cable, TruView Lateral Retractor…score -0.4 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | K072072 | Harmony Led-1 Surgical Lighting SystemSummary page 2…y 12, 2010 Page 8-1 STERIS SPECIAL 510(k) PREMARKET NOTIFICATION Harmony vLED Surgical Lighting System Madification of K072072 Harmony LED-I Surgical Lighting System 1. Device Name Trade Name: Harmony vLED Surgical Ligh… | 2007 |
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 |
|---|---|---|---|---|
| Nov 26, 2014 | Class II | Z-0930-2015 | Software Design Change | STERIS has learned that groups of LED lights (modules) contained within the vLED light head may illuminate inconsistently. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- 5 of the 8 ancestors have a recall of any class.
- 4 other devices also cite its predicate K072072.
How does its category compare?
All FST devicesFST Light, Surgical, Fiberoptic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · FST
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · FST
59in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FST
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FST
27in 2025
MAUDE reports naming product code FST, 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 | 1 | — | 0 | 3 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 3 | 100 | 0 | 4 |
| 2010 | 5 | 90 | 0 | 3 |
| 2011 | 0 | — | 10 | 7 |
| 2012 | 3 | 59 | 0 | 14 |
| 2013 | 0 | — | 0 | 9 |
| 2014 | 1 | — | 1 | 13 |
| 2015 | 0 | — | 0 | 14 |
| 2016 | 0 | — | 0 | 15 |
| 2017 | 0 | — | 0 | 20 |
| 2018 | 0 | — | 0 | 12 |
| 2019 | 0 | — | 0 | 29 |
| 2020 | 1 | — | 0 | 33 |
| 2021 | 0 | — | 0 | 20 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 0 | 11 |
| 2024 | 0 | — | 0 | 40 |
| 2025 | 0 | — | 0 | 27 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Harmony vLED Surgical Lighting System is a variable pattern / intensity surgical light designed to provide visible illumination of the surgical field and the patient and to provide video-visual procedural support for the hospital staff during surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100395 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100395: Harmony Vled Surgical Lightning System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100395
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