510(k) · Cleared
Recalled · Class II · 2015Speculum, Vaginal, Nonmetal
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 Mar 23, 2012 as substantially equivalent to K070964 (Welch Allyn, Inc., 2007) after an 11-day review. Its family tree reaches back 2 generations to 1994. 2 later devices descend from it. It has been recalled once.
- Decided
- Mar 23, 2012
- Review
- 11 days
- Class
- Class II
- Product code
- HIB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K941272 (1994). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK941272 KleenspecWelch Allyn, Inc. · 1994
- 1 generation backK070964 Kleenspec Single Use Vaginal Speculum and 790 Series Cordless…Welch Allyn, Inc. · 2007
- This deviceK120743 Speculum, Vaginal, NonmetalWelch Allyn, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK130046 Clearspec Single Use Vaginal SpeculumClearspec, LLC · 2013
- Descendant · 2 generations on · 0 of its ownK252208 JFord Speculum Sleeve™Ford Medtech, LLC · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K941272 | Kleenspec | Welch Allyn, Inc. | 1994 | — |
| −1 | K070964 | Kleenspec Single Use Vaginal Speculum and 790 Series Cordless Illumination… | Welch Allyn, Inc. | 2007 | — |
| 0 (this device) | K120743 | Speculum, Vaginal, Nonmetal | Welch Allyn, Inc. | 2012 | — |
| +1 | K130046 | Clearspec Single Use Vaginal Speculum | Clearspec, LLC | 2013 | — |
| +2 | K252208 | JFord Speculum Sleeve™ | Ford Medtech, LLC | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 |
|---|---|---|---|
| * | K070964 | Kleenspec Single Use Vaginal Speculum and 790 Series Cordless Illumination SystemSummary page 1…es: KleenSpec® Single Use Vaginal Speculum and 790 series Cordless Illumination System 5 10(k) Number K070964 Indications for Use: KleenSpec® Single Use Vaginal Speculum The disposable vaginal speculumn is used to dilate the vagina and… | 2007 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130046 | Clearspec Single Use Vaginal Speculum | 2013 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 2, 2015 | Class II | Z-0169-2016 | Device Design | The firm became aware that the KleenSpec 788 Corded Illuminator has the potential to be incorrectly connected to a commonly available AC power cord instead of the illuminator low voltage transformer power cord which is supplied with the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 1 company; a new generation was cleared every 12.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K130046 (Clearspec, LLC, 2013) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K070964.
How does its category compare?
All HIB devicesHIB Speculum, Vaginal, Nonmetal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 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.
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/K120743 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120743: Speculum, Vaginal, Nonmetal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120743
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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