510(k) · Cleared
ClearedMach Led 2MC
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 K093010 (Dr. Mach GmbH & Co. KG, 2010) after a 38-day review. Its family tree reaches back 4 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 4 generations to K965130 (1997). 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 backK093010 Mach Led MCDr. Mach GmbH & Co. KG · 2010
- This deviceK140461 Mach Led 2MCDr. Mach GmbH & Co. KG · 2014
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 | K093010 | Mach Led MC | Dr. Mach GmbH & Co. KG | 2010 | — |
| 0 (this device) | K140461 | Mach Led 2MC | Dr. Mach GmbH & Co. KG | 2014 | — |
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 |
|---|---|---|---|
| * | K093010 | Mach Led MCSummary page 4…8092 209350 February 14, 2014 Mach LED 2MC ~ Surgical Lamp Surgical Lamp Regulation 21 CFR 878.4580, Class 11 Product Code: FSY Mach LED MC Surgical lamp 510(k) No. K093010, April 1, 2010 _Dr, Mach Medizinische Leuchten K140461 + Tochnik APR 0 3 20% Summary Mach LED 2MC Dr. Mach GmbHl & Co KG… | 2010 |
| * | — | Mach LED 3MC Named without a submission number | |
| * | — | Mach LED 5MC 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 3 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 1 other device also cites its predicate K093010.
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 2MC is intended to illuminate the operating site on the patient's body with a high intensity, shadow-free and "cold" light.
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/K140461 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140461: Mach Led 2MC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140461
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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