# K041018: DRG Softrelease

- Pathway: 510(k) (Traditional)
- Applicant: Doctor'S Research Group, Inc.
- Decided: Oct 18, 2004 after 181 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: 2 generations back to K832986 (1984). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002520: Rovers Spatula, Rovers Medical Devices B.V. (2000) Summary page 2.
- K971586: Digene Cervical Brush, Digene Corp. (1997) Summary page 2.

## Indications for use
DRG SoftRelease is intended for the collection of cervical cells for Pap smear analysis and/or for detecting sexually transmitted disease (STD). This device is not intended for use in pregnant women.

Source page: https://510kreport.com/device/K041018
Methodology: https://510kreport.com/methodology