# K101537: Aim 200, Major Surgical Light

- Pathway: 510(k) (Traditional)
- Applicant: Burton Medical Products Corp.
- Decided: Sep 30, 2010 after 119 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: 1 generation back to K042395 (2004). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042395: Outpatient Iii Minor Surgery Light, Burton Medical Products Corp. (2004) Summary page 1.

## Most influential descendants
- K132747: Visum Blade Led Surgical Lighting System (2013), 0 descendants of its own

## Indications for use
The AIM 200® OR Major Surgical Light is designed to provide the required illumination for surgeries, procedures, and examinations of patients. The AIM 200® OR Major Surgical Light is to be used with various mounting configurations in operating rooms, examination rooms, emergency rooms and all other health care facilities where the need for additional illumination exists.

Source page: https://510kreport.com/device/K101537
Methodology: https://510kreport.com/methodology