# K780872: Cytology Brush

- Pathway: 510(k) (Traditional)
- Applicant: CooperVision, Inc.
- Decided: Sep 7, 1978 after 100 days
- Product code: BTG (Brush, Biopsy, Bronchoscope (Non-Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K190293: Single Use Cytology Brush BC-205D (2019), 4 descendants of its own
- K192164: Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR (2020), 1 descendant of its own
- K251279: Disposable Cytology Brush BC-202D/203D Series (2025), 0 descendants of its own
- K241679: Disposable Cytology Brush (AF series) (2025), 0 descendants of its own
- K212667: Single Use Guide Sheath Kit-401, K-402 (2021), 0 descendants of its own

## Recalls of this device
- Dec 8, 2005 · Not classified · Z-0376-06: The patient sample may become contaminated because the wax plug, intended to protect the sample from contamination during collection, may be missing.
- Dec 8, 2005 · Not classified · Z-0377-06: The patient sample may become contaminated because the wax plug, intended to protect the sample from contamination during collection, may be missing.

Source page: https://510kreport.com/device/K780872
Methodology: https://510kreport.com/methodology