# K083012: Papcone

- Pathway: 510(k) (Traditional)
- Applicant: Otto Bock Pur Life Science GmbH
- Decided: Apr 9, 2009 after 182 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 K930955 (1994). 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)
- K930955: Cervex-Brush, Rovers B.V. (1994) Summary page 1.
- K961934: Puritan Foam Tip Swab Model 2197, Hardwood Products Co., LP (1996) Summary page 1.

## Indications for use
PapCone® is a medical device intended for the collection of exfoliated cervical cells for analysis by Pap smear methods. The PapCone is not intended for use in pregnant women.

Source page: https://510kreport.com/device/K083012
Methodology: https://510kreport.com/methodology