# K072381: Softpap Cervical Cell Collector

- Pathway: 510(k) (Special)
- Applicant: Cytocore, Inc.
- Decided: Jan 30, 2008 after 159 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: 3 generations back to K832986 (1984). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013258: Inpath E2 Collector, Molecular Diagnostics (2002) Summary page 1.

## Indications for use
For the collection of cervical cytology specimens for Pap test analysis. The SoftPAP M T Cervical Sample Collector should not be used after the first 10 weeks of gestation in pregnant patients.

Source page: https://510kreport.com/device/K072381
Methodology: https://510kreport.com/methodology