# K102758: Trulight 5520 and Trulight 5320

- Pathway: 510(k) (Traditional)
- Applicant: Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg
- Decided: Oct 26, 2010 after 33 days
- Product code: FSY (Light, Surgical, Ceiling Mounted)
- Device class: 2
- Regulation: 21 CFR 878.4580
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K965130 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061317: ILED, Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg (2006) Summary page 1.
- K011693: Trumpf Surgical Lights, Models 301,501,701,1001, Trumpf Medical Systems, Inc. (2001) Summary page 2.

## Cited in the summary but kept off the family tree
- K019246: Surgical Lamp, Mobile. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree

## Recalls of this device
- Nov 2, 2015 · Class II · Z-0563-2016: The firm has received 15 complaints over ten years related to the connection of the spring arm to the top horizontal arm of the lighting system that while positioning the light head enabled the spring
- Jan 9, 2012 · Not classified · Z-1010-2012: The ALC+ function may not be properly locked during use resulting in the possibility of the handle falling off into the surgical field causing injury to the patient.

## 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/K102758
Methodology: https://510kreport.com/methodology