# K960880: Mill-Rose Blind Microbiology Brush

- Pathway: 510(k) (Traditional)
- Applicant: Mill-Rose Laboratory
- Decided: Apr 29, 1996 after 56 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- 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 K820771 (1982). 2 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K820771: Microbiology Specimen Brush, Mill-Rose Laboratory (1982) Summary page 1.
- K923487: Bal Cath, Ballard Medical Products (1993) Summary page 1.

## Most influential descendants
- K993614: Fas Endoluminal Brush (2000), 3 descendants of its own
- 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 device is intended to allow blind, non-directed, protected specimen brush sampling of the lower respiratory tract secretions or to perform surveillance cultures or to diagnose pneumonia in patients receiving mechanical ventilation.

Source page: https://510kreport.com/device/K960880
Methodology: https://510kreport.com/methodology