510(k) · Cleared
ClearedTrojan Magnum Condom with Warming Lubricant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Church & Dwight Virginia Co., Inc. · HIS Condom
Cleared on May 11, 2012 as substantially equivalent to K895640 (Armkel, LLC, 1990) and 2 other predicates after a 105-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- May 11, 2012
- Review
- 105 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K897129 (1990). 5 ancestors in all, the oldest K895640 (1990). No later device cites it as a predicate yet.
- Root · 3 generations backK897129 Condoms (Multiple Brands)Sagami, Inc. · 1990
- 2 generations backK071272 Trojan Thintensity Brand Male Latex CondomChurch & Dwight Co., Inc. · 2007
- 1 generation backK073016 Trojan Thintensity Brand Male Latex Condom Lubricated with…Church & Dwight Co., Inc. · 2007
- This deviceK120249 Trojan Magnum Condom with Warming LubricantChurch & Dwight Virginia Co., Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K897129 | Condoms (Multiple Brands) | Sagami, Inc. | 1990 | — |
| −2 | K071272 | Trojan Thintensity Brand Male Latex Condom | Church & Dwight Co., Inc. | 2007 | — |
| −1 | K073016 | Trojan Thintensity Brand Male Latex Condom Lubricated with Ultrasmooth and… | Church & Dwight Co., Inc. | 2007 | — |
| 0 (this device) | K120249 | Trojan Magnum Condom with Warming Lubricant | Church & Dwight Virginia Co., Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 2000 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K895640 | Magnum Plus Latex Condom W/Spermicidal LubricantSummary page 1…Condom [21ICFR §884.5300] HIS Predicate Device: TROJAN®'MAGNUM® Latex Condom with Spermicidal Silicone Lubricant (K895640) TROJAN" THIN TENS ITYTm Latex Condom with Warm Sensations TM Lubri… | 1990 |
| * | K073016 | Trojan Thintensity Brand Male Latex Condom Lubricated with Ultrasmooth and Warm…Summary page 1…Lubricant (K895640) TROJAN" THIN TENS ITYTm Latex Condom with Warm Sensations TM Lubricant (K0730 16) TROJAN® EXTENDED PLEASURETM Latex Condom with Climax Control Lubri… | 2007 |
| * | K000748 | Trojan Latex Condom with Male Genital Desensitizer LubricantSummary page 1…Lubricant (K0730 16) TROJAN® EXTENDED PLEASURETM Latex Condom with Climax Control Lubricant (K000748) Descripion of Device The TROJAN® MAGNUM® Condom with WARMING m Lubricant is a male condom consisting of a sheath of natural ru… | 2000 |
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 22 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All HIS devicesHIS Condom: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
TROJAN® MAGNUM® Condom with WARMING Tm 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/K120249 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120249: Trojan Magnum Condom with Warming Lubricant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120249
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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