510(k) · Cleared
ClearedVag O Speculum, Models VS1, VM1, VL1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Panatrex, Inc. · HIB Speculum, Vaginal, Nonmetal
Cleared on Nov 30, 2004 after a 35-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Nov 30, 2004
- Review
- 35 days
- Class
- Class II
- Product code
- HIB
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK042950 Vag O Speculum, Models VS1, VM1, VL1Panatrex, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK052420 G-Spec Articulated Weighted Vaginal SpeculumGynova, LLC · 2006
Most influential descendants
Showing 1 of 1 · See all- K052420G-Spec Articulated Weighted Vaginal SpeculumGynova, LLC · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042950 | Vag O Speculum, Models VS1, VM1, VL1 | Panatrex, Inc. | 2004 | — |
| +1 | K052420 | G-Spec Articulated Weighted Vaginal Speculum | Gynova, LLC | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 |
|---|---|---|---|
| * | — | Kleenspec (Welch Allyn Vaginal Speculum) Named without a submission number |
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 |
|---|---|---|---|
| K052420 | G-Spec Articulated Weighted Vaginal Speculum | 2006 | 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?
- Of its descendants, K052420 (Gynova, LLC, 2006) has gone furthest, with 0 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 | — |
What is it indicated for?
To be used by medical professionals to expose the interior of the vagina to facilitate visualization during gynecological and obstetrical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042950 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042950: Vag O Speculum, Models VS1, VM1, VL1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042950
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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