# K861389: Pap Smear Kit

- Pathway: 510(k) (Traditional)
- Applicant: Intl. Cytobrush, Inc.
- Decided: May 2, 1986 after 18 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
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 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
- K182049: exCellerator Cervical Collection Device (2019), 0 descendants of its own
- K153128: Kolplast Cervical Sample Collection Kit (2017), 0 descendants of its own
- K062433: Diamics Cercol Cervical Sample Collector System (2007), 0 descendants of its own

Source page: https://510kreport.com/device/K861389
Methodology: https://510kreport.com/methodology