510(k) · Cleared
ClearedTrojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe 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 Sep 9, 2016 as substantially equivalent to K131887 (Church & Dwight Co., Inc., 2013) after a 59-day review. Its family tree reaches back 2 generations to 1992.
- Decided
- Sep 9, 2016
- Review
- 59 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K912901 (1992). No later device cites it as a predicate yet.
- Root · 2 generations backK912901 Trojan (TM-TBD) CondomCarter Products · 1992
- 1 generation backK131887 Trojan Jaguar Male Natural Rubber Latex Condom with Warming and…Church & Dwight Co., Inc. · 2013
- This deviceK161915 Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone…Church & Dwight Co., Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K912901 | Trojan (TM-TBD) Condom | Carter Products | 1992 | — |
| −1 | K131887 | Trojan Jaguar Male Natural Rubber Latex Condom with Warming and Tingling… | Church & Dwight Co., Inc. | 2013 | — |
| 0 (this device) | K161915 | Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe… | Church & Dwight Co., Inc. | 2016 | — |
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 |
|---|---|---|---|
| * | K131887 | Trojan Jaguar Male Natural Rubber Latex Condom with Warming and Tingling LubricantSummary page 5…: NEW DEVICE: PREDICATE DEVICE: Characteristic K161915 K131887 Indications for Use For contraception and for prophylactic purposes (to… | 2013 |
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 24 years and passes through 2 companies; a new generation was cleared every 21.7 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K131887.
How does its category compare?
All HIS devicesHIS Condom: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 XOXO Intense Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Vera OE Lubricant 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/K161915 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161915: Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161915
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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