510(k) · Cleared
ClearedClearspec Single Use Vaginal Speculum
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clearspec, LLC · HIB Speculum, Vaginal, Nonmetal
Cleared on Aug 6, 2013 as substantially equivalent to K050887 (Zhejiang Gongdong Medical Plastic Factory, 2005) and 1 other predicate after a 210-day review. Its family tree reaches back 3 generations to 1994. 1 later device descends from it.
- Decided
- Aug 6, 2013
- Review
- 210 days
- Class
- Class II
- Product code
- HIB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K941272 (1994). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK941272 KleenspecWelch Allyn, Inc. · 1994
- 2 generations backK070964 Kleenspec Single Use Vaginal Speculum and 790 Series Cordless…Welch Allyn, Inc. · 2007
- 1 generation backK120743 Speculum, Vaginal, NonmetalWelch Allyn, Inc. · 2012 · Recalled
- This deviceK130046 Clearspec Single Use Vaginal SpeculumClearspec, LLC · 2013
- Descendant · cites it directly · 0 of its ownK252208 JFord Speculum Sleeve™Ford Medtech, LLC · 2026
Most influential descendants
Showing 1 of 1 · See all- K252208JFord Speculum Sleeve™Ford Medtech, LLC · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K941272 | Kleenspec | Welch Allyn, Inc. | 1994 | — |
| −2 | 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 |
| 0 (this device) | K130046 | Clearspec Single Use Vaginal Speculum | Clearspec, LLC | 2013 | — |
| +1 | K252208 | JFord Speculum Sleeve™ | Ford Medtech, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K050887 | Gongdong Disposable Vaginal SpeculumSummary page 1…Speculum, Vaginal, Nonmetal Classification: Class 11per 21 CFR 884.4530, Product Code: HIB Predicate Device: Gongdong Disposable Vaginal Speculum (K050887) Welch Allyn KleenSpec® Single Use Vaginal Speculum (K120743) Device Description: The ClearSpec® Single U… | 2005 |
| * | K120743 | Speculum, Vaginal, NonmetalSummary page 1…4530, Product Code: HIB Predicate Device: Gongdong Disposable Vaginal Speculum (K050887) Welch Allyn KleenSpec® Single Use Vaginal Speculum (K120743) Device Description: The ClearSpec® Single Use Vaginal Speculum is a disposable vaginal speculum constructed of polystyrene, use… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252208 | JFord Speculum Sleeve™ | 2026 | 0 |
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 19 years and passes through 2 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K252208 (Ford Medtech, LLC, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K050887.
How does its category compare?
All HIB devicesHIB Speculum, Vaginal, Nonmetal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 ClearSpec® Single-Use 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130046 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130046: Clearspec Single Use Vaginal Speculum.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130046
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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