510(k) · Cleared
ClearedKleenspec Single Use Vaginal Speculum and 790 Series Cordless Illumination System
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 May 18, 2007 as substantially equivalent to K941272 (Welch Allyn, Inc., 1994) after a 43-day review. Its family tree reaches back 1 generation to 1994. 6 later devices descend from it.
- Decided
- May 18, 2007
- Review
- 43 days
- Class
- Class II
- Product code
- HIB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K941272 (1994). 6 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK941272 KleenspecWelch Allyn, Inc. · 1994
- This deviceK070964 Kleenspec Single Use Vaginal Speculum and 790 Series Cordless…Welch Allyn, Inc. · 2007
- Descendant · cites it directly · 2 of its ownK120743 Speculum, Vaginal, NonmetalWelch Allyn, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 1 of its ownK130046 Clearspec Single Use Vaginal SpeculumClearspec, LLC · 2013
- Descendant · cites it directly · 1 of its ownK072762 Depalt Vaginal Specuim and Depalt Lighting SystemDepalt, Inc. · 2008
- Descendant · 3 generations on · 0 of its ownK252208 JFord Speculum Sleeve™Ford Medtech, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK133857 Brella-Spec (TM) Vaginal SpeculumProa Medical, Inc. · 2014
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K120743Speculum, Vaginal, NonmetalWelch Allyn, Inc. · 2012 · cites it directly2descendants
- K130046Clearspec Single Use Vaginal SpeculumClearspec, LLC · 2013 · 2 generations on1descendant
- K072762Depalt Vaginal Specuim and Depalt Lighting SystemDepalt, Inc. · 2008 · cites it directly1descendant
- K252208JFord Speculum Sleeve™Ford Medtech, LLC · 2026 · 3 generations on0descendants
- K133857Brella-Spec (TM) Vaginal SpeculumProa Medical, Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K941272 | Kleenspec | Welch Allyn, Inc. | 1994 | — |
| 0 (this device) | K070964 | Kleenspec Single Use Vaginal Speculum and 790 Series Cordless Illumination… | Welch Allyn, Inc. | 2007 | — |
| +1 | K120743 | Speculum, Vaginal, Nonmetal | Welch Allyn, Inc. | 2012 | 1 |
| +2 | K130046 | Clearspec Single Use Vaginal Speculum | Clearspec, LLC | 2013 | — |
| +1 | K072762 | Depalt Vaginal Specuim and Depalt Lighting System | Depalt, Inc. | 2008 | — |
| +3 | K252208 | JFord Speculum Sleeve™ | Ford Medtech, LLC | 2026 | — |
| +2 | K133857 | Brella-Spec (TM) Vaginal Speculum | Proa Medical, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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.
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? (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 |
|---|---|---|---|
| * | K941272 | KleenspecSummary page 1…Illumination System (Special 510(k)) Classification: 21 CFR § 884.4530; Class II Predicate Device: KleenSpec Disposable Vaginal Speculumn 580 series (1K941272) Description: The disposable vaginal speculum is used to dilate the vagina and expose the inte… | 1994 |
What descends from it? (6)
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?
How does its category compare?
All HIB devicesHIB Speculum, Vaginal, Nonmetal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
KleenSpec® Single Use Vaginal Speculum
The disposable vaginal speculum is used to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures.
The vaginal speculum can be used with or without the illuminator.
KleenSpec® 790 Series Cordless Illuminator
When used with the vaginal speculum, the cordless illuminator provides illumination during pelvic examinations and other gynecological procedures, such as pap smears, dilation and curettage (D&C), biopsy, and electrosurgery.
The illuminator can be used independent of the speculum as a general-purpose light source.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070964 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070964: Kleenspec Single Use Vaginal Speculum and 790 Series Cordless Illumination System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070964
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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