Submission Details
| 510(k) Number | K252208 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
JFord Speculum Sleeve?
Mar 2026
Decision
234d
Days
Class 2
Risk
About This 510(k) Submission
K252208 is an FDA 510(k) clearance for the JFord Speculum Sleeve?, 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 review panel. Regulated under 21 CFR 884.4530.
Device Classification
| Product Code | HIB — Speculum, Vaginal, Nonmetal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4530 |
Manufacturer
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