K252208 is an FDA 510(k) clearance for the JFord Speculum Sleeve™. This device is classified as a Speculum, Vaginal, Nonmetal (Class II - Special Controls, product code HIB).
Submitted by Ford Medtech, LLC (Westbury, US). The FDA issued a Cleared decision on March 6, 2026, 234 days after receiving the submission on July 15, 2025.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K252208 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 2025 |
| Decision Date | March 06, 2026 |
| Days to Decision | 234 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HIB — Speculum, Vaginal, Nonmetal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4530 |