510(k) · Cleared
ClearedTrojan Polyurethane Condom
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carter Products · MOL Condom, Synthetic
Cleared on Jun 22, 1995 after a 379-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.
- Decided
- Jun 22, 1995
- Review
- 379 days
- Class
- Class II
- Product code
- MOL
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK942697 Trojan Polyurethane CondomCarter Products · 1995
- Descendant · cites it directly · 1 of its ownK050828 Trojan Supra Lubricated Polyurethane Male CondomChurch & Dwight Co., Inc. · 2006
- Descendant · 2 generations on · 0 of its ownK080752 Conceivex Latex-Free Semen CollectorConceivex, Inc. · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K942697 | Trojan Polyurethane Condom | Carter Products | 1995 | — |
| +1 | K050828 | Trojan Supra Lubricated Polyurethane Male Condom | Church & Dwight Co., Inc. | 2006 | — |
| +2 | K080752 | Conceivex Latex-Free Semen Collector | Conceivex, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 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 MOL? 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 MOL device
- #1 K252158 Sagami Original 002 Polyurethane Male Condomscore 11.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050828 | Trojan Supra Lubricated Polyurethane Male Condom | 2006 | 1 |
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, K050828 (Church & Dwight Co., Inc., 2006) has gone furthest, with 1 descendant of its own.
How does its category compare?
All MOL devicesMOL Condom, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MOL
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MOL
244in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOL
3in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MOL
4in 2025
MAUDE reports naming product code MOL, 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 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 5 |
| 2016 | 1 | — | 0 | 4 |
| 2017 | 2 | — | 0 | 9 |
| 2018 | 1 | — | 3 | 11 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 3 | 244 | 0 | 2 |
| 2025 | 2 | — | 0 | 4 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K942697 · printed Nov 6, 2026
Cite this page
510(k) Report. “K942697: Trojan Polyurethane Condom.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K942697
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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