510(k) · Cleared
ClearedMach Led 2SC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dr. Mach GmbH & Co. KG · FSY Light, Surgical, Ceiling Mounted
Cleared on Apr 3, 2014 as substantially equivalent to K093009 (Dr. Mach GmbH & Co. KG, 2010) after a 38-day review. Its family tree reaches back 5 generations to 1997.
- Decided
- Apr 3, 2014
- Review
- 38 days
- Class
- Class II
- Product code
- FSY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K965130 (1997). 9 ancestors in all, the oldest K904965 (1991). No later device cites it as a predicate yet.
- Root · 5 generations backK965130 ChromophareBerchtold Holding GmbH · 1997
- 4 generations backK024132 Chromophare X 65Berchtold Holding GmbH · 2003
- 3 generations backK061317 ILEDTrumpf Kreuzer Medizin Systeme GmbH + Co.Kg · 2006 · Recalled
- 2 generations backK072072 Harmony Led-1 Surgical Lighting SystemSTERIS Corporation · 2007 · Recalled
- 1 generation backK093009 Mach Led SCDr. Mach GmbH & Co. KG · 2010
- This deviceK140460 Mach Led 2SCDr. Mach GmbH & Co. KG · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K965130 | Chromophare | Berchtold Holding GmbH | 1997 | — |
| −4 | K024132 | Chromophare X 65 | Berchtold Holding GmbH | 2003 | — |
| −3 | K061317 | ILED | Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg | 2006 | 7 |
| −2 | K072072 | Harmony Led-1 Surgical Lighting System | STERIS Corporation | 2007 | 1 |
| −1 | K093009 | Mach Led SC | Dr. Mach GmbH & Co. KG | 2010 | — |
| 0 (this device) | K140460 | Mach Led 2SC | Dr. Mach GmbH & Co. KG | 2014 | — |
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 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? (3)
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 |
|---|---|---|---|
| * | K093009 | Mach Led SCSummary page 1…580, Class 11 Product Code: FSY Predicate Device Mach LED SC Surgical lamp 5 10(k) No. K093009, April 1, 2010 Summary Mach LED 2SC Dr. Mach (3mbl & Co KG Page 1 of")… | 2010 |
| * | — | Mach LED 3SC Named without a submission number | |
| * | — | Mach LED 5SC Named without a submission number |
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 17 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 5 of the 9 ancestors have a recall of any class.
- 2 other devices also cite its predicate K093009.
How does its category compare?
All FSY devicesFSY Light, Surgical, Ceiling Mounted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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 Mach LED 2SC is intended to illuminate the surgical field and the patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140460 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140460: Mach Led 2SC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140460
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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