# K140812: MI-750 Procedural/Minor Surgical Light

- Pathway: 510(k) (Traditional)
- Applicant: Medical Illumination International, Inc.
- Decided: Aug 7, 2014 after 128 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). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083066: Chromophare E 778 and E 558, Berchtold Holding GmbH (2008) Summary page 4.
- K113679: Lucea Led Surgical Light System, Maquet S.A.S. (2012) Summary page 4.
- K100388: 21ST Century Centurion Exceled and System Two Led Lighting Systems, Medical Illumination International, Inc. (2010). Our reading of the summary gave K100338, which is not a number in FDA’s lists. Corrected to the number one digit away that FDA lists under the company the summary names beside it.

## Indications for use
The MI-750 is a fixed pattern / three level intensity procedural/minor surgical light designed to provide visible illumination of the surgical field and the patient during minor surgical and non-surgical procedures.

Source page: https://510kreport.com/device/K140812
Methodology: https://510kreport.com/methodology