510(k) · Cleared
ClearedConceivex Conception Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conceivex, Inc. · OBB Kit, Conception-Assist, Home Use
Cleared on Mar 14, 2007 as substantially equivalent to K993953 (Veos, Ltd., 2000) and 1 other predicate after a 141-day review. Its family tree reaches back 1 generation to 1991. 3 later devices descend from it.
- Decided
- Mar 14, 2007
- Review
- 141 days
- Class
- Class II
- Product code
- OBB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K902936 (1991). 2 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK902936 Polyurethane CondomApex Medical Technologies, Inc. · 1991
- This deviceK063227 Conceivex Conception KitConceivex, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK112200 Focus Touch Conception SystemIntimate Bridge 2 Conception, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK140186 The Stork OtcRinovum Women'S Health, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK080752 Conceivex Latex-Free Semen CollectorConceivex, Inc. · 2008
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902936 | Polyurethane Condom | Apex Medical Technologies, Inc. | 1991 | — |
| 0 (this device) | K063227 | Conceivex Conception Kit | Conceivex, Inc. | 2007 | — |
| +1 | K112200 | Focus Touch Conception System | Intimate Bridge 2 Conception, Inc. | 2012 | — |
| +2 | K140186 | The Stork Otc | Rinovum Women'S Health, Inc. | 2014 | — |
| +1 | K080752 | Conceivex Latex-Free Semen Collector | Conceivex, Inc. | 2008 | — |
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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 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? (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 |
|---|---|---|---|
| * | K993953 | Oves Cervical CapSummary page 1…ces in the Conceivex Conception Kit are being submitted in this Premarket Notification, each with a new Indication for Use. The first predicate is the Oves Cervical Cap, K993953. The second is the Durex Avanti Polyurethane Condom, K902936. B. Device Description The Conceivex Conception Kit includes the f… | 2000 |
| * | K902936 | Polyurethane CondomSummary page 1…is Premarket Notification, each with a new Indication for Use. The first predicate is the Oves Cervical Cap, K993953. The second is the Durex Avanti Polyurethane Condom, K902936. B. Device Description The Conceivex Conception Kit includes the following literature: Instructions for Use, a "Conception Whee… | 1991 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 OBB devicesOBB Kit, Conception-Assist, Home Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Conceivex Conception Kit is indicated for assisted insemination in situations in which low sperm count, sperm immobility, or hostile vaginal environment have been diagnosed. The kit is used for semen collection and placement into the bowl of a cervical cap as an aid to conception. It is to be used at home following physician instruction. The Cap should not be left in place for longer than 6 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063227 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063227: Conceivex Conception Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063227
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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