510(k) · Cleared
ClearedGinram Specuvag, Ginram Specuvag as, Ginram Cuscovag, Models 720101, 720102, 720103, 720179, 720227, 720043
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ri Mos. S.R.L. · HIB Speculum, Vaginal, Nonmetal
Cleared on Jul 19, 1999 as substantially equivalent to K941272 (Welch Allyn, Inc., 1994) after a 52-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Jul 19, 1999
- Review
- 52 days
- Class
- Class II
- Product code
- HIB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K941272 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK941272 KleenspecWelch Allyn, Inc. · 1994
- This deviceK991827 Ginram Specuvag, Ginram Specuvag as, Ginram Cuscovag, Models 720101…Ri Mos. S.R.L. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K941272 | Kleenspec | Welch Allyn, Inc. | 1994 | — |
| 0 (this device) | K991827 | Ginram Specuvag, Ginram Specuvag as, Ginram Cuscovag, Models 720101, 720102… | Ri Mos. S.R.L. | 1999 | — |
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 |
|---|---|---|---|
| * | K941272 | KleenspecSummary page 1…. s.r.l. devices known as the GINRAM® Cuscovag, Specuvag and Specuvag AS. 3. The above device is substantially equivalent to KleenSpec® Specula marketed by Welch Allyn, K941272. 4. The RI. MOS. s.r.l. speculae line are sterile, single-use, disposable devices. 5. The device is intended as an aid in routi… | 1994 |
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K941272.
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 RI MOS. s.r.l. Cuscovag, Specuvag and Specuvag AS devices are used to expose the interior of the vagina. The Cuscovag is indicated as an aid for routine examination in adolescent and geriatric women, the Specuvag as an aid for routine examination and the Specuvag AS as an aid for routine examination and procedures where smoke must be evacuated from the vaginal canal.
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/K991827 · printed Nov 5, 2026
Cite this page
510(k) Report. “K991827: Ginram Specuvag, Ginram Specuvag as, Ginram Cuscovag, Models 720101, 720102, 720103, 720179, 720227, 720043.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991827
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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