510(k) · Cleared
ClearedTROJAN SIS Synthetic Latex Condom with Silicone Lubricant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Church & Dwight Co., Inc. · MOL Condom, Synthetic
Cleared on Oct 8, 2024 as substantially equivalent to K171639 (Church & Dwight Co., Inc., 2017) after a 244-day review. Its family tree reaches back 2 generations to 2011.
- Decided
- Oct 8, 2024
- Review
- 244 days
- Class
- Class II
- Product code
- MOL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K100767 (2011). No later device cites it as a predicate yet.
- Root · 2 generations backK100767 Trojan Supra Lubricated Polyurethane Male CondomChurch & Dwight Co., Inc. · 2011
- 1 generation backK171639 Trojan Supra Lubricated Polyurethane Male CondomChurch & Dwight Co., Inc. · 2017
- This deviceK240379 TROJAN SIS Synthetic Latex Condom with Silicone LubricantChurch & Dwight Co., Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K100767 | Trojan Supra Lubricated Polyurethane Male Condom | Church & Dwight Co., Inc. | 2011 | — |
| −1 | K171639 | Trojan Supra Lubricated Polyurethane Male Condom | Church & Dwight Co., Inc. | 2017 | — |
| 0 (this device) | K240379 | TROJAN SIS Synthetic Latex Condom with Silicone Lubricant | Church & Dwight Co., Inc. | 2024 | — |
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 |
|---|---|---|---|
| * | K171639 | Trojan Supra Lubricated Polyurethane Male CondomSummary page 5…thetic Condom Product Code: MOL (condom, synthetic) Regulatory Class: Class II Classification Name: Condom (21 CFR § 884.5300) Predicate Device: K171639: TROJAN™ SUPRA Lubricated Polyurethane Male Condom The predicate device has not been subject to a design… | 2017 |
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 1 company; a new generation was cleared every 7.2 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All MOL devicesMOL Condom, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
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 TROJAN SIS Synthetic Latex Condom with Silicone Lubricant is used for contraception and for prophylactic purposes (to prevent pregnancy and the transmission of sexually transmitted infections).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240379 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240379: TROJAN SIS Synthetic Latex Condom with Silicone Lubricant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240379
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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