510(k) · Cleared
ClearedKarl Storz Infant, Balloon Vaginoscope, Vaginoscope Sheath, Fiber Optic Light Carriers, Adjustable Magnifiers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · MOK Vaginoscope And Accessories
Cleared on Jun 19, 1995 after a 126-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.
- Decided
- Jun 19, 1995
- Review
- 126 days
- Class
- Class II
- Product code
- MOK
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK950639 Karl Storz Infant, Balloon Vaginoscope, Vaginoscope Sheath, Fiber…KARL STORZ Endoscopy-America, Inc. · 1995
- Descendant · cites it directly · 0 of its ownK220969 GelPOINT V-Path Vaginal Access SystemApplied Medical Resources Corporation · 2022
Most influential descendants
Showing 1 of 1 · See all- K220969GelPOINT V-Path Vaginal Access SystemApplied Medical Resources Corporation · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K950639 | Karl Storz Infant, Balloon Vaginoscope, Vaginoscope Sheath, Fiber Optic Light… | KARL STORZ Endoscopy-America, Inc. | 1995 | — |
| +1 | K220969 | GelPOINT V-Path Vaginal Access System | Applied Medical Resources Corporation | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MOK? 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 MOK device
- #1 K220969 GelPOINT V-Path Vaginal Access Systemscore 4.0 · 1 generation · no Class I recall
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
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 |
|---|---|---|---|
| K220969 | GelPOINT V-Path Vaginal Access System | 2022 | 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?
- Of its descendants, K220969 (Applied Medical Resources Corporation, 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MOK devicesMOK Vaginoscope And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MOK
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · MOK
Too few MOK 510(k)s in any year since 2007 to give a median.
Recalls per year · MOK
No recall names MOK since 2007.
Adverse event reports per year · MOK
1in 2020
MAUDE reports naming product code MOK, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K950639 · printed Nov 6, 2026
Cite this page
510(k) Report. “K950639: Karl Storz Infant, Balloon Vaginoscope, Vaginoscope Sheath, Fiber Optic Light Carriers, Adjustable Magnifiers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950639
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026