510(k) · Cleared
ClearedJFord Speculum Sleeve™
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ford Medtech, LLC · HIB Speculum, Vaginal, Nonmetal
Cleared on Mar 6, 2026 as substantially equivalent to K130046 (Clearspec, LLC, 2013) after a 234-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Mar 6, 2026
- Review
- 234 days
- Class
- Class II
- Product code
- HIB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K941272 (1994). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK941272 KleenspecWelch Allyn, Inc. · 1994
- 3 generations backK070964 Kleenspec Single Use Vaginal Speculum and 790 Series Cordless…Welch Allyn, Inc. · 2007
- 2 generations backK120743 Speculum, Vaginal, NonmetalWelch Allyn, Inc. · 2012 · Recalled
- 1 generation backK130046 Clearspec Single Use Vaginal SpeculumClearspec, LLC · 2013
- This deviceK252208 JFord Speculum Sleeve™Ford Medtech, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K941272 | Kleenspec | Welch Allyn, Inc. | 1994 | — |
| −3 | K070964 | Kleenspec Single Use Vaginal Speculum and 790 Series Cordless Illumination… | Welch Allyn, Inc. | 2007 | — |
| −2 | K120743 | Speculum, Vaginal, Nonmetal | Welch Allyn, Inc. | 2012 | 1 |
| −1 | K130046 | Clearspec Single Use Vaginal Speculum | Clearspec, LLC | 2013 | — |
| 0 (this device) | K252208 | JFord Speculum Sleeve™ | Ford Medtech, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HIB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K130046 | Clearspec Single Use Vaginal SpeculumSummary page 5…Regulatory Class: 2 Product Code: HIB 3. Predicate Device Predicate Device: ClearSpec® Single Use Vaginal Speculum (K130046) The predicate has not been subject to a design-related recall. 4. Device Description The JFord Speculum Sleeve™… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 3 companies; a new generation was cleared every 12.6 years on median.
- 1 of the 5 ancestors has a recall of any class.
How does its category compare?
All HIB devicesHIB Speculum, Vaginal, Nonmetal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · HIB
2in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · HIB
Too few HIB 510(k)s in any year since 2007 to give a median.
Recalls per year · HIB
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HIB
3in 2025
MAUDE reports naming product code HIB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 1 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 10 |
| 2011 | 1 | — | 0 | 15 |
| 2012 | 1 | — | 0 | 15 |
| 2013 | 1 | — | 0 | 9 |
| 2014 | 2 | — | 0 | 8 |
| 2015 | 0 | — | 1 | 5 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 5 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K252208 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252208: JFord Speculum Sleeve™.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252208
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026