# K141136: Leica FL800

- Pathway: 510(k) (Traditional)
- Applicant: Leica Biosystems Richmond
- Decided: Aug 19, 2014 after 110 days
- Product code: IZI (System, X-Ray, Angiographic)
- Device class: 2
- Regulation: 21 CFR 892.1600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K944261 (1994). 9 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061871: Leica Model FL800, Leica Microsystems, Inc. (2006) Summary page 4.
- K080612: Leica FL800, Leica Microsystems (Schweiz) AG (2008) Summary page 4.

## Most influential descendants
- K190772: SURGICAL MICROSCOPE SYSTEM ORBEYE with IR (2019), 0 descendants of its own
- K181537: GLOW800 (2018), 0 descendants of its own
- K170239: Leica FL560 (2017), 0 descendants of its own

## Indications for use
The Leica FL800 is a Leica Surgical Microscope accessory used in viewing intra-operative blood flow in the cerebral vascular area and bypass grafts during coronary artery bypass (CABG) surgery, as well as blood flow during plastic and reconstructive surgery.

Source page: https://510kreport.com/device/K141136
Methodology: https://510kreport.com/methodology