# K011693: Trumpf Surgical Lights, Models 301,501,701,1001

- Pathway: 510(k) (Traditional)
- Applicant: Trumpf Medical Systems, Inc.
- Decided: Jun 13, 2001 after 13 days
- Product code: FSY (Light, Surgical, Ceiling Mounted)
- Device class: 2
- Regulation: 21 CFR 878.4580
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K984611 (1999). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984611: Drager Sola Series, Models 1000/700/500/300, Drager Medizintechnik GmbH (1999) Summary page 1.

## Most influential descendants
- K102758: Trulight 5520 and Trulight 5320 (2010), 0 descendants of its own
- K091246: Iled 3 Mobile (I300M), Trulight 5500 Mobile (T500M), Trulight 5300 Mobile (T300M) (2009), 0 descendants of its own

## Recalls of this device
- Jul 27, 2015 · Class II · Z-2355-2015: Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor.
- Feb 19, 2013 · Class II · Z-0484-2014: Possible fatigue failure of the plastic joint may occur after an average use of seven years.
- Sep 19, 2012 · Class II · Z-0077-2013: Incidents regarding fractures of the front joint of the spring arm have been reported.

## Indications for use
The Trumpf surgical lights are intended to locally illuminate an operating or examination area of the patient’s body with high intensity light.

Source page: https://510kreport.com/device/K011693
Methodology: https://510kreport.com/methodology