# K003489: Next General M20 Surgical Light; Next Generation M16 Minor Surgery Light; Next Generation Spotlight; Next Generation M8

- Pathway: 510(k) (Traditional)
- Applicant: Medical Illumination International, Inc.
- Decided: Feb 2, 2001 after 81 days
- Product code: FSS (Light, Surgical, Floor Standing)
- 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K100702: Startrol Led Lighting Systems (X=# of Pods, Y=# of Leds, N=to Mounting Style) Model X X Y -N-S-W. X=Number of Light Pods (2010), 0 descendants of its own

Source page: https://510kreport.com/device/K003489
Methodology: https://510kreport.com/methodology