# K153128: Kolplast Cervical Sample Collection Kit

- Pathway: 510(k) (Traditional)
- Applicant: Kolplast CI SA
- Decided: Jan 13, 2017 after 442 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 K861389 (1986). 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)
- K861389: Pap Smear Kit, Intl. Cytobrush, Inc. (1986) Summary page 4.

## Indications for use
The Kolplast Cervical Sample Collection Kit is intended for collection of cytological specimens from the ectocervix and the endocervix for conventional Pap Smear Test or Liquid-Based ThinPrep® Pap Test with PreservCyt® solution. For prescription use only. It is not intended for use in pregnant women and should be used by a clinical or other qualified health professional only.

Source page: https://510kreport.com/device/K153128
Methodology: https://510kreport.com/methodology