# K141057: Disposable Cervical Brush

- Pathway: 510(k) (Traditional)
- Applicant: Ningbo Hls Medical Products Co., Ltd.
- Decided: May 14, 2015 after 385 days
- Product code: HHT (Spatula, Cervical, Cytological)
- Device class: 2
- Regulation: 21 CFR 884.4530
- 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 K896065 (1990). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K896065: Wallach CC/Brush, Wallach Surgical Devices, Inc. (1990) Summary page 4.

## Indications for use
The Disposable Cervical Brush is intended for the collection of cervical cells for analysis by Pap smear methods. It is not intended for use in pregnant women and should be used by a clinician or other qualified health professional only.

Source page: https://510kreport.com/device/K141057
Methodology: https://510kreport.com/methodology