# K991963: Patton Speculum

- Pathway: 510(k) (Traditional)
- Applicant: Patton Medical Corp.
- Decided: Sep 1, 1999 after 83 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 K891351 (1989). 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)
- K984211: Medscand Disposable Plastic Vaginal Speculum; Easy-Spec Plastic Vaginal Speculum, Model 303, Medscand AB (1998) Summary page 1.
- K891351: Newport Lateral Vaginal Retractor, Simpson/Basye, Inc. (1989) Summary page 1.

## Indications for use
The Patton SpeculunTu is intended for use to retract the vagina in diagnostic and therapeutic obstetrical and gynecological procedures.

Source page: https://510kreport.com/device/K991963
Methodology: https://510kreport.com/methodology