# K252208: JFord Speculum Sleeve™

- Pathway: 510(k) (Traditional)
- Applicant: Ford Medtech, LLC
- Decided: Mar 6, 2026 after 234 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: 4 generations back to K941272 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130046: Clearspec Single Use Vaginal Speculum, Clearspec, LLC (2013) Summary page 5.

## Indications for use
The JFord Speculum Sleeve™ is a single use, inflatable vaginal wall retraction sleeve intended for use with a vaginal speculum to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures.

Source page: https://510kreport.com/device/K252208
Methodology: https://510kreport.com/methodology