510(k) · Cleared
ClearedTrojan Jaguar Male Natural Rubber Latex Condom with Warming and Tingling Lubricant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Church & Dwight Co., Inc. · HIS Condom
Cleared on Oct 24, 2013 as substantially equivalent to K912901 (Carter Products, 1992) after a 121-day review. Its family tree reaches back 1 generation to 1992. 3 later devices descend from it.
- Decided
- Oct 24, 2013
- Review
- 121 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K912901 (1992). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK912901 Trojan (TM-TBD) CondomCarter Products · 1992
- This deviceK131887 Trojan Jaguar Male Natural Rubber Latex Condom with Warming and…Church & Dwight Co., Inc. · 2013
- Descendant · cites it directly · 0 of its ownK221906 TROJAN Fire & Ice lubricated male natural rubber latex condomChurch & Dwight Co., Inc. · 2022
- Descendant · cites it directly · 0 of its ownK221431 TROJAN (TM) Her Pleasure Warming male natural rubber latex condom…Church & Dwight Co., Inc. · 2022
- Descendant · cites it directly · 0 of its ownK161915 Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone…Church & Dwight Co., Inc. · 2016
Most influential descendants
Showing 3 of 3 · See all- K221906TROJAN Fire & Ice lubricated male natural rubber latex condomChurch & Dwight Co., Inc. · 2022 · cites it directly0descendants
- K221431TROJAN (TM) Her Pleasure Warming male natural rubber latex condom with warming lubricantChurch & Dwight Co., Inc. · 2022 · cites it directly0descendants
- K161915Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe LubricantChurch & Dwight Co., Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912901 | Trojan (TM-TBD) Condom | Carter Products | 1992 | — |
| 0 (this device) | K131887 | Trojan Jaguar Male Natural Rubber Latex Condom with Warming and Tingling… | Church & Dwight Co., Inc. | 2013 | — |
| +1 | K221906 | TROJAN Fire & Ice lubricated male natural rubber latex condom | Church & Dwight Co., Inc. | 2022 | — |
| +1 | K221431 | TROJAN (TM) Her Pleasure Warming male natural rubber latex condom with warming… | Church & Dwight Co., Inc. | 2022 | — |
| +1 | K161915 | Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe… | Church & Dwight Co., Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2022 | 2 | 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 HIS? 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 HIS device
- #1 K262108 FAMA Male Latex Condoms – Aqueous Lubricant…score 13.2 · 5 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 |
|---|---|---|---|
| * | K912901 | Trojan (TM-TBD) CondomSummary page 1…Rubber Latex Condom with Lubricant Name: Classification Condom (21 CER §884.5300) HIS Name: Predicate TROJANTh (TMv-TBD) Latex Condom with Lubricant (K912901) Device: [Secondary Brand Name HER PLEASURETh added when introduced to market] Description of… | 1992 |
What descends from it? (3)
3 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 HIS devicesHIS Condom: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · HIS
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HIS
99in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HIS
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HIS
20in 2025
MAUDE reports naming product code HIS, 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 | 7 | 128 | 1 | 10 |
| 2008 | 3 | 157 | 0 | 11 |
| 2009 | 5 | 241 | 0 | 12 |
| 2010 | 1 | — | 0 | 22 |
| 2011 | 3 | 54 | 0 | 15 |
| 2012 | 7 | 106 | 1 | 10 |
| 2013 | 4 | 208 | 1 | 19 |
| 2014 | 7 | 242 | 0 | 16 |
| 2015 | 3 | 136 | 0 | 8 |
| 2016 | 5 | 115 | 0 | 5 |
| 2017 | 4 | 102 | 0 | 8 |
| 2018 | 2 | — | 0 | 11 |
| 2019 | 1 | — | 0 | 15 |
| 2020 | 4 | 240 | 0 | 12 |
| 2021 | 5 | 233 | 0 | 16 |
| 2022 | 10 | 112 | 0 | 18 |
| 2023 | 2 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 5 | 99 | 0 | 20 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The TROJAN Jaguar Male Natural Rubber Latex Condom with Warming and Tingling Lubricant (TM-TBD) is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131887 · printed Nov 5, 2026
Cite this page
510(k) Report. “K131887: Trojan Jaguar Male Natural Rubber Latex Condom with Warming and Tingling Lubricant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K131887
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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