510(k) · Cleared
ClearedWallach's Ultimate Reusable, Plastic Vaginal Speculum
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wallach Surgical Devices, Inc. · HIB Speculum, Vaginal, Nonmetal
Cleared on Sep 29, 1999 as substantially equivalent to K935636 (Adept-Med Intl., Inc., 1994) and 1 other predicate after a 47-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Sep 29, 1999
- Review
- 47 days
- Class
- Class II
- Product code
- HIB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K935636 (1994). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK935636 GravespecAdept-Med Intl., Inc. · 1994
- This deviceK992736 Wallach's Ultimate Reusable, Plastic Vaginal SpeculumWallach Surgical Devices, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K935636 | Gravespec | Adept-Med Intl., Inc. | 1994 | — |
| 0 (this device) | K992736 | Wallach's Ultimate Reusable, Plastic Vaginal Speculum | Wallach Surgical Devices, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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? (2)
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 |
|---|---|---|---|
| * | K935636 | GravespecSummary page 1…HIB, Regulation Number 884.4530, 21 CFR. Predicate Devices to which we are claiming substantial equivalence: Adept-Med's Gravespec Reusable Nonmetal, Vaginal Speculum, K935636, 03/25/94. CooperSurgical's Prima Series, Vaginal LEEP Plastic Reusable Specula, K951898, 12/11/95. Product Description: The Ul… | 1994 |
| * | K951898 | Versa-VUSummary page 1…tantial equivalence: Adept-Med's Gravespec Reusable Nonmetal, Vaginal Speculum, K935636, 03/25/94. CooperSurgical's Prima Series, Vaginal LEEP Plastic Reusable Specula, K951898, 12/11/95. Product Description: The Ultimate Reusable, Plastic Vaginal Speculum is a device used to expose the interior of the… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 2 ancestors has a recall.
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 Wallach Ultimate Reusable, Plastic Vaginal Speculum is intended to be used for general gynecologic and electrosurgical procedures. This product is inserted into the vagina to expose the 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/K992736 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992736: Wallach's Ultimate Reusable, Plastic Vaginal Speculum.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992736
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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