# K140461: Mach Led 2MC

- Pathway: 510(k) (Special)
- Applicant: Dr. Mach GmbH & Co. KG
- Decided: Apr 3, 2014 after 38 days
- Product code: FSY (Light, Surgical, Ceiling Mounted)
- Device class: 2
- Regulation: 21 CFR 878.4580
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K965130 (1997). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093010: Mach Led MC, Dr. Mach GmbH & Co. KG (2010) Summary page 4.
- (no number) Mach LED 3MC: named in the summary without a submission number
- (no number) Mach LED 5MC: named in the summary without a submission number

## Indications for use
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.

Source page: https://510kreport.com/device/K140461
Methodology: https://510kreport.com/methodology