510(k) · Cleared
ClearedGongdong Disposable Vaginal Speculum
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhejiang Gongdong Medical Plastic Factory · HIB Speculum, Vaginal, Nonmetal
Cleared on Jul 11, 2005 after a 95-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Jul 11, 2005
- Review
- 95 days
- Class
- Class II
- Product code
- HIB
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK050887 Gongdong Disposable Vaginal SpeculumZhejiang Gongdong Medical Plastic Factory · 2005
- 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
- Descendant · cites it directly · 0 of its ownK092870 Non-Sterile Disposable Vaginal SpeculumKunshan Deyi Plastic Co., Ltd. · 2010
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K050887 | Gongdong Disposable Vaginal Speculum | Zhejiang Gongdong Medical Plastic Factory | 2005 | — |
| +1 | K130046 | Clearspec Single Use Vaginal Speculum | Clearspec, LLC | 2013 | — |
| +2 | K252208 | JFord Speculum Sleeve™ | Ford Medtech, LLC | 2026 | — |
| +1 | K092870 | Non-Sterile Disposable Vaginal Speculum | Kunshan Deyi Plastic Co., Ltd. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
2 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?
- Of its descendants, K130046 (Clearspec, LLC, 2013) 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?
The Gongdong Disposable'Vaginal Speculum is non sterile products and is intended to be used by a medical professional to expose the interior of the vagina to facilitate visualization during the obstetrical and gynecological procedures.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K050887 · printed Nov 5, 2026
Cite this page
510(k) Report. “K050887: Gongdong Disposable Vaginal Speculum.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K050887
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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