510(k) · Cleared
ClearedDRG Disposable Vaginal Speculum
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Doctor'S Research Group, Inc. · HIB Speculum, Vaginal, Nonmetal
Cleared on Mar 1, 2002 as substantially equivalent to K000414 (Marketing Perspectives, 2000) and 1 other predicate after a 206-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it.
- Decided
- Mar 1, 2002
- Review
- 206 days
- Class
- Class II
- Product code
- HIB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K984211 (1998). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK984211 Medscand Disposable Plastic Vaginal Speculum; Easy-Spec Plastic…Medscand AB · 1998
- This deviceK012535 DRG Disposable Vaginal SpeculumDoctor'S Research Group, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK041757 Femspec Disposable Vaginal SpeculumFemspec LLC · 2004
Most influential descendants
Showing 1 of 1 · See all- K041757Femspec Disposable Vaginal SpeculumFemspec LLC · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K984211 | Medscand Disposable Plastic Vaginal Speculum; Easy-Spec Plastic Vaginal… | Medscand AB | 1998 | — |
| 0 (this device) | K012535 | DRG Disposable Vaginal Speculum | Doctor'S Research Group, Inc. | 2002 | — |
| +1 | K041757 | Femspec Disposable Vaginal Speculum | Femspec LLC | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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? (3)
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 |
|---|---|---|---|
| * | K000414 | Medisul Disposable Vaginal SpeculumSummary page 2…cation Panel: Obstetrics/Gynecology Regulation number: 21CFR Part 884.4530 Class: ] Product Code: HiB [Ro12535 ANC [ 2535 fl«g.g Z%L?_ Predicate Device K000414 — Medisul Disposable Vaginal Speculum™ K984211 — Medscand Easy-Spec™ Disposable Vaginal Speculum Welch Allyn Disposable Vaginal S… | 2000 |
| * | K984211 | Medscand Disposable Plastic Vaginal Speculum; Easy-Spec Plastic Vaginal Speculum, Model…Summary page 2…number: 21CFR Part 884.4530 Class: ] Product Code: HiB [Ro12535 ANC [ 2535 fl«g.g Z%L?_ Predicate Device K000414 — Medisul Disposable Vaginal Speculum™ K984211 — Medscand Easy-Spec™ Disposable Vaginal Speculum Welch Allyn Disposable Vaginal Speculum Device Description The DRG Disposable… | 1998 |
| * | — | Welch Allyn Disposable 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 |
|---|---|---|---|
| K041757 | Femspec Disposable Vaginal Speculum | 2004 | 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?
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 DRG Disposable Vaginal Speculum is indicated for diagnostic procedures of the vagina and cervix.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012535 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012535: DRG 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/K012535
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026