# K241679: Disposable Cytology Brush (AF series)

- Pathway: 510(k) (Traditional)
- Applicant: Alton (Shanghai) Medical Instruments Co., Ltd.
- Decided: Mar 4, 2025 after 266 days
- Product code: KTI (Bronchoscope Accessory)
- 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: 2 generations back to K780872 (1978). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190293: Single Use Cytology Brush BC-205D, Olympus Medical Systems Corp. (2019) Summary page 5.

## Indications for use
The cytology brush has been specifically designed to collect specimens or cells endoscopically for cytologic examination in conjunction with bronchoscopes. Intended patient population: Adults

Source page: https://510kreport.com/device/K241679
Methodology: https://510kreport.com/methodology