# K012535: DRG Disposable Vaginal Speculum

- Pathway: 510(k) (Traditional)
- Applicant: Doctor'S Research Group, Inc.
- Decided: Mar 1, 2002 after 206 days
- Product code: HIB (Speculum, Vaginal, Nonmetal)
- 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 K984211 (1998). 2 ancestors in all.
1 later device descends from it; 1 cites 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)
- K000414: Medisul Disposable Vaginal Speculum, Marketing Perspectives (2000) Summary page 2.
- K984211: Medscand Disposable Plastic Vaginal Speculum; Easy-Spec Plastic Vaginal Speculum, Model 303, Medscand AB (1998) Summary page 2.
- (no number) Welch Allyn Disposable Vaginal Speculum: named in the summary without a submission number

## Most influential descendants
- K041757: Femspec Disposable Vaginal Speculum (2004), 0 descendants of its own

## Indications for use
The DRG Disposable Vaginal Speculum is indicated for diagnostic procedures of the vagina and cervix.

Source page: https://510kreport.com/device/K012535
Methodology: https://510kreport.com/methodology