# K140460: Mach Led 2SC

- 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: 5 generations back to K965130 (1997). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093009: Mach Led SC, Dr. Mach GmbH & Co. KG (2010) Summary page 1.
- (no number) Mach LED 3SC: named in the summary without a submission number
- (no number) Mach LED 5SC: named in the summary without a submission number

## Indications for use
The surgical light Mach LED 2SC is intended to illuminate the surgical field and the patient.

Source page: https://510kreport.com/device/K140460
Methodology: https://510kreport.com/methodology