510(k) · Cleared
ClearedMach Led SC
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 K072072 (STERIS Corporation, 2007) and 1 other predicate after a 184-day review. Its family tree reaches back 4 generations to 1997. 4 later devices descend from it.
- Decided
- Apr 1, 2010
- Review
- 184 days
- Class
- Class II
- Product code
- FSY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K965130 (1997). 8 ancestors in all, the oldest K904965 (1991). 4 later devices descend from it, 3 citing it directly.
- 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 deviceK093009 Mach Led SCDr. Mach GmbH & Co. KG · 2010
- Descendant · cites it directly · 1 of its ownK132307 Vida Led Surgical Lighting SystemConvida Healthcare & Systems Corporation · 2013
- Descendant · 2 generations on · 0 of its ownK140930 Vida Led Surgical Lighting System, V SeriesConvida Healthcare & Systems Corporation · 2014
- Descendant · cites it directly · 0 of its ownK140460 Mach Led 2SCDr. 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 4 of 4 · See all- K132307Vida Led Surgical Lighting SystemConvida Healthcare & Systems Corporation · 2013 · cites it directly1descendant
- K140930Vida Led Surgical Lighting System, V SeriesConvida Healthcare & Systems Corporation · 2014 · 2 generations on0descendants
- K140460Mach Led 2SCDr. Mach GmbH & Co. KG · 2014 · cites it directly0descendants
- K131893Amico CE Series Surgical Lights, Mira Led Series Minor Surgical LightsAjw Technology Consultants, Inc. · 2013 · cites it directly0descendants
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) | K093009 | Mach Led SC | Dr. Mach GmbH & Co. KG | 2010 | — |
| +1 | K132307 | Vida Led Surgical Lighting System | Convida Healthcare & Systems Corporation | 2013 | — |
| +2 | K140930 | Vida Led Surgical Lighting System, V Series | Convida Healthcare & Systems Corporation | 2014 | — |
| +1 | K140460 | Mach Led 2SC | Dr. Mach GmbH & Co. KG | 2014 | — |
| +1 | K131893 | Amico CE Series Surgical Lights, Mira Led Series Minor Surgical Lights | Ajw Technology Consultants, Inc. | 2013 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 2 | 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? (2)
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…ations for Use: The surgical light Mach LED SC is intended to illuminate the surgical field and the patient. Predicate Devices: Harmony LED-i1 Surgical Lighting System (K072072), STERIS Corporation POWERLED SURGICAL LIGHT SYSTEM (K070442), MAQUET S.A. Substantial Equivalence: The Mach LED SC is substanti… | 2007 |
| * | K070442 | Powerled Surgical Light SystemSummary page 2…illuminate the surgical field and the patient. Predicate Devices: Harmony LED-i1 Surgical Lighting System (K072072), STERIS Corporation POWERLED SURGICAL LIGHT SYSTEM (K070442), MAQUET S.A. Substantial Equivalence: The Mach LED SC is substantially equivalent to the surgical light Harmony LED-i Surgical… | 2007 |
What descends from it? (4)
3 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 4 companies; a new generation was cleared every 3.3 years on median.
- 5 of the 8 ancestors have a recall of any class.
- Of its descendants, K132307 (Convida Healthcare & Systems Corporation, 2013) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K072072.
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 SC is intended to illuminate the surgical field and the patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093009 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093009: Mach Led SC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093009
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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