# K993614: Fas Endoluminal Brush

- Pathway: 510(k) (Traditional)
- Applicant: Fas Medical, Ltd.
- Decided: Jan 18, 2000 after 85 days
- Product code: LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5970
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K820771 (1982). 5 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971586: Digene Cervical Brush, Digene Corp. (1997) Summary page 1.
- K960880: Mill-Rose Blind Microbiology Brush, Mill-Rose Laboratory (1996) Summary page 1.

## Most influential descendants
- K050889: Fibrin Analysis System Endoluminal Brush (2005), 1 descendant of its own
- K012641: Fas Endoluminal Brush (2001), 1 descendant of its own
- K072518: CRS Fibrin Analysis Catheter Testing System (Facts) (2007), 0 descendants of its own

## Indications for use
The FAS Endoluminal Brush is intended to collect a biofilm or fibrin sample, which is suitable for microbiological analysis, from the inner lumen surface of an in-dwelling central venous catheter.

Source page: https://510kreport.com/device/K993614
Methodology: https://510kreport.com/methodology