JFord Speculum Sleeve— 510(k) K252208
Substantially EquivalentFord Medtech, LLC
FDA 510(k) clearance K252208 for JFord Speculum Sleeve, Substantially Equivalent on 2026-03-06. Applicant: Ford Medtech, LLC. Device class: 2.
Summary
Ford Medtech's JFord Speculum Sleeve is filed under HIB, nonmetal vaginal specula. The record doesn't list sizes.
Class II, 21 CFR 884.4530. Obstetrics/Gynecology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Ford Medtech filed from Westbury, New York. Review took 234 calendar days (July 15, 2025 to March 6, 2026).
Clearance details
- Applicant
- Ford Medtech, LLC
- Product code
- Product code HIB
- Device class
- Class 2
- Regulation
- 21 CFR 884.4530
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westbury, NY, US
Recent devices under product code HIB
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