510(k) · Cleared
ClearedKleenspec
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Welch Allyn, Inc. · HIB Speculum, Vaginal, Nonmetal
Cleared on Aug 2, 1994 after a 139-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 9 later devices descend from it.
- Decided
- Aug 2, 1994
- Review
- 139 days
- Class
- Class II
- Product code
- HIB
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 3 citing it directly.
- This deviceK941272 KleenspecWelch Allyn, Inc. · 1994
- Descendant · cites it directly · 6 of its ownK070964 Kleenspec Single Use Vaginal Speculum and 790 Series Cordless…Welch Allyn, Inc. · 2007
- Descendant · 2 generations on · 2 of its ownK120743 Speculum, Vaginal, NonmetalWelch Allyn, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 1 of its ownK130046 Clearspec Single Use Vaginal SpeculumClearspec, LLC · 2013
- Descendant · 2 generations on · 1 of its ownK072762 Depalt Vaginal Specuim and Depalt Lighting SystemDepalt, Inc. · 2008
- Descendant · 4 generations on · 0 of its ownK252208 JFord Speculum Sleeve™Ford Medtech, LLC · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K070964Kleenspec Single Use Vaginal Speculum and 790 Series Cordless Illumination SystemWelch Allyn, Inc. · 2007 · cites it directly6descendants
- K120743Speculum, Vaginal, NonmetalWelch Allyn, Inc. · 2012 · 2 generations on2descendants
- K130046Clearspec Single Use Vaginal SpeculumClearspec, LLC · 2013 · 3 generations on1descendant
- K072762Depalt Vaginal Specuim and Depalt Lighting SystemDepalt, Inc. · 2008 · 2 generations on1descendant
- K252208JFord Speculum Sleeve™Ford Medtech, LLC · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K941272 | Kleenspec | Welch Allyn, Inc. | 1994 | — |
| +1 | 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 |
| +3 | K130046 | Clearspec Single Use Vaginal Speculum | Clearspec, LLC | 2013 | — |
| +2 | K072762 | Depalt Vaginal Specuim and Depalt Lighting System | Depalt, Inc. | 2008 | — |
| +4 | K252208 | JFord Speculum Sleeve™ | Ford Medtech, LLC | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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.
Top candidate predicates for a new HIB device
- #1 K252208 JFord Speculum Sleeve™score 11.9 · 4 generations · no Class I recall
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K070964 (Welch Allyn, Inc., 2007) has gone furthest, with 6 descendants of its own.
How does its category compare?
All HIB devicesHIB Speculum, Vaginal, Nonmetal: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K941272 · printed Nov 6, 2026
Cite this page
510(k) Report. “K941272: Kleenspec.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941272
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026