510(k) · Cleared
ClearedTrojan (TM-TBD) Condom
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carter Products · HIS Condom
Cleared on Feb 3, 1992 after a 216-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.
- Decided
- Feb 3, 1992
- Review
- 216 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 4 citing it directly.
- This deviceK912901 Trojan (TM-TBD) CondomCarter Products · 1992
- Descendant · cites it directly · 3 of its ownK131887 Trojan Jaguar Male Natural Rubber Latex Condom with Warming and…Church & Dwight Co., Inc. · 2013
- Descendant · cites it directly · 1 of its ownK120286 Trojan Her Pleasure (Ribbed) Ecstasy Latex Condom with LubricantChurch & Dwight Co., Inc. · 2012
- Descendant · cites it directly · 1 of its ownK984488 Sheer ThinTwe Companies, Inc. · 1999
- Descendant · 2 generations on · 0 of its ownK243640 Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™…Church & Dwight Co., Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK221906 TROJAN Fire & Ice lubricated male natural rubber latex condomChurch & Dwight Co., Inc. · 2022
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K131887Trojan Jaguar Male Natural Rubber Latex Condom with Warming and Tingling LubricantChurch & Dwight Co., Inc. · 2013 · cites it directly3descendants
- K120286Trojan Her Pleasure (Ribbed) Ecstasy Latex Condom with LubricantChurch & Dwight Co., Inc. · 2012 · cites it directly1descendant
- K984488Sheer ThinTwe Companies, Inc. · 1999 · cites it directly1descendant
- K243640Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy)Church & Dwight Co., Inc. · 2025 · 2 generations on0descendants
- K221906TROJAN Fire & Ice lubricated male natural rubber latex condomChurch & Dwight Co., Inc. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +1 | K120286 | Trojan Her Pleasure (Ribbed) Ecstasy Latex Condom with Lubricant | Church & Dwight Co., Inc. | 2012 | — |
| +1 | K984488 | Sheer Thin | Twe Companies, Inc. | 1999 | — |
| +2 | K243640 | Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed… | Church & Dwight Co., Inc. | 2025 | — |
| +2 | K221906 | TROJAN Fire & Ice lubricated male natural rubber latex condom | Church & Dwight Co., Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2005 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 2 | 0 |
| 2022 | 2 | 0 |
| 2025 | 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 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 13.3 · 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (9)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131887 | Trojan Jaguar Male Natural Rubber Latex Condom with Warming and Tingling Lubricant | 2013 | 3 |
| K120286 | Trojan Her Pleasure (Ribbed) Ecstasy Latex Condom with Lubricant | 2012 | 1 |
| K984488 | Sheer Thin | 1999 | 1 |
| K161545 | Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant | 2016 | 0 |
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, K131887 (Church & Dwight Co., Inc., 2013) has gone furthest, with 3 descendants of its own.
How does its category compare?
All HIS devicesHIS Condom: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K912901 · printed Nov 3, 2026
Cite this page
510(k) Report. “K912901: Trojan (TM-TBD) Condom.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K912901
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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