510(k) · Cleared
ClearedDynarex Vaginal Specula 4900, Models 4911-Small, 4912-Medium, 4913-Large
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dynarex Corp. · HIB Speculum, Vaginal, Nonmetal
Cleared on Nov 9, 2005 as substantially equivalent to K020726 (Dukal Corp., 2002) after a 76-day review. Its family tree reaches back 1 generation to 2002. 2 later devices descend from it.
- Decided
- Nov 9, 2005
- Review
- 76 days
- Class
- Class II
- Product code
- HIB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K020726 (2002). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK020726 Dukal Disposable Vaginal Speculum, Small, Medium, and LargeDukal Corp. · 2002
- This deviceK052314 Dynarex Vaginal Specula 4900, Models 4911-Small, 4912-Medium…Dynarex Corp. · 2005
- Descendant · cites it directly · 1 of its ownK072762 Depalt Vaginal Specuim and Depalt Lighting SystemDepalt, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK133857 Brella-Spec (TM) Vaginal SpeculumProa Medical, Inc. · 2014
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 |
|---|---|---|---|---|---|
| −1 | K020726 | Dukal Disposable Vaginal Speculum, Small, Medium, and Large | Dukal Corp. | 2002 | — |
| 0 (this device) | K052314 | Dynarex Vaginal Specula 4900, Models 4911-Small, 4912-Medium, 4913-Large | Dynarex Corp. | 2005 | — |
| +1 | K072762 | Depalt Vaginal Specuim and Depalt Lighting System | Depalt, Inc. | 2008 | — |
| +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 |
| 2014 | 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 |
|---|---|---|---|
| * | K020726 | Dukal Disposable Vaginal Speculum, Small, Medium, and LargeSummary page 1…Instrument (21 CFR 884.4530) Predicate Device Dukal Vaginal Speculum 510(k) #: K020726 Intended Use The Dynarex Vaginal Specula is used to expose the interi… | 2002 |
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 |
|---|---|---|---|
| K072762 | Depalt Vaginal Specuim and Depalt Lighting System | 2008 | 1 |
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?
- Its one ancestor has no recall.
- Of its descendants, K072762 (Depalt, Inc., 2008) has gone furthest, with 1 descendant 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?
This device is used to expose the interior of the vagina.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052314 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052314: Dynarex Vaginal Specula 4900, Models 4911-Small, 4912-Medium, 4913-Large.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052314
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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