# K941272: Kleenspec

- Pathway: 510(k) (Traditional)
- Applicant: Welch Allyn, Inc.
- Decided: Aug 2, 1994 after 139 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
No predicates in its family tree.
9 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K070964: Kleenspec Single Use Vaginal Speculum and 790 Series Cordless Illumination System (2007), 6 descendants of its own
- K120743: Speculum, Vaginal, Nonmetal (2012), 2 descendants of its own
- K130046: Clearspec Single Use Vaginal Speculum (2013), 1 descendant of its own
- K072762: Depalt Vaginal Specuim and Depalt Lighting System (2008), 1 descendant of its own
- K252208: JFord Speculum Sleeve™ (2026), 0 descendants of its own

Source page: https://510kreport.com/device/K941272
Methodology: https://510kreport.com/methodology