510(k) · Cleared
ClearedMach Led MC
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 1, 2010 as substantially equivalent to K061317 (Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg, 2006) after a 184-day review. Its family tree reaches back 3 generations to 1997. 2 later devices descend from it.
- Decided
- Apr 1, 2010
- Review
- 184 days
- Class
- Class II
- Product code
- FSY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K965130 (1997). 2 later devices descend from it, 2 citing it directly.
- 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 deviceK093010 Mach Led MCDr. Mach GmbH & Co. KG · 2010
- Descendant · cites it directly · 0 of its ownK140461 Mach Led 2MCDr. Mach GmbH & Co. KG · 2014
- Descendant · cites it directly · 0 of its ownK131893 Amico CE Series Surgical Lights, Mira Led Series Minor Surgical LightsAjw Technology Consultants, Inc. · 2013
Most influential descendants
Showing 2 of 2 · See allView 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) | K093010 | Mach Led MC | Dr. Mach GmbH & Co. KG | 2010 | — |
| +1 | K140461 | Mach Led 2MC | Dr. Mach GmbH & Co. KG | 2014 | — |
| +1 | K131893 | Amico CE Series Surgical Lights, Mira Led Series Minor Surgical Lights | Ajw Technology Consultants, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 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? (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 |
|---|---|---|---|
| * | K061317 | ILEDSummary page 2…rgical light Mach LED MC is intended to illuminate the operating site on the patient's body with a high intensity, shadow-free and "cold" light. Predicate Device: iLED (K061317), Trumpf Kreuzer Medizin System GmbH Substantial Equivalence: The Mach LED MC is substantially equivalent to the surgical light… | 2006 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 13 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K140461 (Dr. Mach GmbH & Co. KG, 2014) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K061317.
How does its category compare?
All FSY devicesFSY Light, Surgical, Ceiling Mounted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 MC is intended to illuminate the operating site on the patient's body with a high intensity, shadow-free and "cold" light.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093010 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093010: Mach Led MC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093010
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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