510(k) · Cleared
ClearedConceivex Latex-Free Semen Collector
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 May 14, 2008 as substantially equivalent to K050828 (Church & Dwight Co., Inc., 2006) and 1 other predicate after a 58-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- May 14, 2008
- Review
- 58 days
- Class
- Class II
- Product code
- OBB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K942697 (1995). 5 ancestors in all, the oldest K902936 (1991). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K942697 | Trojan Polyurethane Condom | Carter Products | 1995 | — |
| −1 | K050828 | Trojan Supra Lubricated Polyurethane Male Condom | Church & Dwight Co., Inc. | 2006 | — |
| 0 (this device) | K080752 | Conceivex Latex-Free Semen Collector | Conceivex, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2000 | 1 | 0 |
| 2007 | 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? (4)
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 |
|---|---|---|---|
| * | K050828 | Trojan Supra Lubricated Polyurethane Male CondomSummary page 1…ex Latex-free Semen Collector Classification Name: Condom, Synthetic A. Predicate Devices The predicate devices are the Trojan Supra Polyurethane Condom, cleared under K050828, and the Conceivex Semen Collector cleared under K063227. B. Device Description The subject device is a polyurethane condom. C… | 2006 |
| * | K063227 | Conceivex Conception KitSummary page 1…, Synthetic A. Predicate Devices The predicate devices are the Trojan Supra Polyurethane Condom, cleared under K050828, and the Conceivex Semen Collector cleared under K063227. B. Device Description The subject device is a polyurethane condom. C. Intended Use The Semen Collection Device is intended t… | 2007 |
| * | — | Sagami condom Named without a submission number | |
| * | — | Avanti Semen Collection device Named without a submission number |
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 13 years and passes through 3 companies; a new generation was cleared every 10.7 years on median.
- None of the 5 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. 2008, 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 Sagami Polyurethane Semen Collection Device is intended to be used as an accessory to the Oves Cervical Cap to collect semen for transfer to the cap prior to insertion in artificial insemination procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080752 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080752: Conceivex Latex-Free Semen Collector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080752
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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