510(k) · Cleared
ClearedThe Stork Otc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rinovum Women'S Health, Inc. · OBB Kit, Conception-Assist, Home Use
Cleared on Jul 11, 2014 as substantially equivalent to K112200 (Intimate Bridge 2 Conception, Inc., 2012) after a 168-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- Jul 11, 2014
- Review
- 168 days
- Class
- Class II
- Product code
- OBB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K902936 (1991). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK902936 Polyurethane CondomApex Medical Technologies, Inc. · 1991
- 2 generations backK063227 Conceivex Conception KitConceivex, Inc. · 2007
- 1 generation backK112200 Focus Touch Conception SystemIntimate Bridge 2 Conception, Inc. · 2012
- This deviceK140186 The Stork OtcRinovum Women'S Health, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K902936 | Polyurethane Condom | Apex Medical Technologies, Inc. | 1991 | — |
| −2 | K063227 | Conceivex Conception Kit | Conceivex, Inc. | 2007 | — |
| −1 | K112200 | Focus Touch Conception System | Intimate Bridge 2 Conception, Inc. | 2012 | — |
| 0 (this device) | K140186 | The Stork Otc | Rinovum Women'S Health, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 OBB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K112200 | Focus Touch Conception SystemSummary page 1…Manufacturer Device Name 510(k) Number Predicate Devices: Rinovum Women's The Focus Touch® K1 12200 Health, Inc Conception System Reason for Submission: New Indicati… | 2012 |
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?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 5.5 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All OBB devicesOBB Kit, Conception-Assist, Home Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · OBB
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · OBB
Too few OBB 510(k)s in any year since 2007 to give a median.
Recalls per year · OBB
No recall names OBB since 2007.
Adverse event reports per year · OBB
2in 2023
MAUDE reports naming product code OBB, 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 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 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 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Stork® OTC is indicated for over-the-counter home use by couples who have been unable to conceive naturally and who have received a diagnosis of low sperm count, sperm immobility or unfavorable vaginal environment. The Stork® OTC contains a cervical cap inside a condom-like silicone sheath. It is used to collect semen into a cervical cap then deliver it to the outside of the cervix as an aid to conception. The Stork® OTC should be used during the ovulatory phase of the menstrual cycle. The Stork® OTC Cervical Cap should not be left in place for longer than six hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140186 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140186: The Stork Otc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140186
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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