510(k) · Cleared
ClearedTrojan for Women
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Armkel, LLC · HIS Condom
Cleared on Apr 4, 1989 after a 42-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 16 later devices descend from it.
- Decided
- Apr 4, 1989
- Review
- 42 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 2 citing it directly.
- This deviceK890863 Trojan for WomenArmkel, LLC · 1989
- Descendant · cites it directly · 7 of its ownK013433 Trojan Passion Berry GelArmkel, LLC · 2002
- Descendant · cites it directly · 7 of its ownK013614 Trojan Crystal Clear LiquidArmkel, LLC · 2002
- Descendant · 2 generations on · 6 of its ownK120751 Nirvana B Personal LubricantChurch & Dwight Co., Inc. · 2012
- Descendant · 2 generations on · 6 of its ownK023405 Trojan Mint Tingle Brand Latex CondomsArmkel, LLC · 2002
- Descendant · 3 generations on · 5 of its ownK103119 Billy Boy Male Latex CondomSheila Pickering PHD · 2011
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K013433Trojan Passion Berry GelArmkel, LLC · 2002 · cites it directly7descendants
- K013614Trojan Crystal Clear LiquidArmkel, LLC · 2002 · cites it directly7descendants
- K120751Nirvana B Personal LubricantChurch & Dwight Co., Inc. · 2012 · 2 generations on6descendants
- K023405Trojan Mint Tingle Brand Latex CondomsArmkel, LLC · 2002 · 2 generations on6descendants
- K103119Billy Boy Male Latex CondomSheila Pickering PHD · 2011 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K890863 | Trojan for Women | Armkel, LLC | 1989 | — |
| +1 | K013433 | Trojan Passion Berry Gel | Armkel, LLC | 2002 | — |
| +1 | K013614 | Trojan Crystal Clear Liquid | Armkel, LLC | 2002 | — |
| +2 | K120751 | Nirvana B Personal Lubricant | Church & Dwight Co., Inc. | 2012 | — |
| +2 | K023405 | Trojan Mint Tingle Brand Latex Condoms | Armkel, LLC | 2002 | — |
| +3 | K103119 | Billy Boy Male Latex Condom | Sheila Pickering PHD | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 13.2 · 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (16)
See all 162 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?
- Of its descendants, K013433 (Armkel, LLC, 2002) has gone furthest, with 7 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/K890863 · printed Nov 6, 2026
Cite this page
510(k) Report. “K890863: Trojan for Women.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K890863
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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