510(k) · Cleared
ClearedTrojan Polyurethane Condom (Modification)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carter Products · MOL Condom, Synthetic
Cleared on Aug 29, 1996 after a 302-day review. The FDA summary names its predicate without a number.
- Decided
- Aug 29, 1996
- Review
- 302 days
- Class
- Class II
- Product code
- MOL
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 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? (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 |
|---|---|---|---|
| * | — | TROJAN® Latex Condoms 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.
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 | — |
What is it indicated for?
The subject polyurethane condom has the same intended use as the predicate latex condoms. The condom 1s used for contraceptive and for prophylactic purposes (helping to prevent transmission of venereal disease). If used properly, condoms will help to reduce the risk of transmission of HIV intection (AIDS) and many other sexually transmitled discases, including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis. No…
Read the full statement (226 words)
The subject polyurethane condom has the same intended use as the predicate latex condoms. The condom 1s used for contraceptive and for prophylactic purposes (helping to prevent transmission of venereal disease). If used properly, condoms will help to reduce the risk of transmission of HIV intection (AIDS) and many other sexually transmitled discases, including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis. No contraceptive can guarantee 100% effectiveness. Any use of thc condom for other than vaginal intercourse can incrcase the potential of damage to the condom. For maximurmn benefits, it is important to follow the instructions for use that accompany the product. Failure to do so may result in the loss of the benefits of a condom. During intimate contact, lesions and various body fluids can transmit sexually transmitted diseases (STDs); therefore, a new condom should be applied each and every time before any such contact occurs, The condom with spermicidal lubricant combines the use of a condom with a spermicidal lubricant. The spermicide, nonoxynol-9, reduces the number of active sperm. thereby decreasing the risk of pregnancy if erection is lost before withdrawal and some semen spills outside the condom. However, the extent of decreased risk has not been established. A condom with spermicidal lubricant should not be used as a substitute for the combined use of a vaginal spermicide and a condom.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K955672 · printed Nov 6, 2026
Cite this page
510(k) Report. “K955672: Trojan Polyurethane Condom (Modification).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955672
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026