# K022948: Vaginal Speculum, Model 5555S, 5555M, or 5555L

- Pathway: 510(k) (Traditional)
- Applicant: Medical Action Industries, Inc.
- Decided: Nov 4, 2002 after 60 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: 2 generations back to K000414 (2000). 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)
- K021017: Leespec Disposable Vaginal Speculum, Itl Corporation Pty, Ltd. (2002) Summary page 1.

## Indications for use
Vaginal Speculums are single use and shall be used to expose the interior of the vagina.

Source page: https://510kreport.com/device/K022948
Methodology: https://510kreport.com/methodology