510(k) · Cleared
ClearedTrojan Passion Berry Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Armkel, LLC · NUC Lubricant, Personal
Cleared on Mar 5, 2002 as substantially equivalent to K890863 (Armkel, LLC, 1989) after a 140-day review. Its family tree reaches back 1 generation to 1989. 7 later devices descend from it.
- Decided
- Mar 5, 2002
- Review
- 140 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K890863 (1989). 7 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK890863 Trojan for WomenArmkel, LLC · 1989
- This deviceK013433 Trojan Passion Berry GelArmkel, LLC · 2002
- Descendant · cites it directly · 6 of its ownK023405 Trojan Mint Tingle Brand Latex CondomsArmkel, LLC · 2002
- Descendant · 2 generations on · 5 of its ownK103119 Billy Boy Male Latex CondomSheila Pickering PHD · 2011
- Descendant · 3 generations on · 1 of its ownK120394 Lifestyles Zero Lubricated Latex CondomAnsell Heathcare Products, LLC · 2012 · Recalled
- Descendant · 3 generations on · 1 of its ownK111093 Billy Boy Male Latex CondomMapa GmbH · 2011
- Descendant · 4 generations on · 0 of its ownK153016 aoni Natural Rubber Latex CondomGuangzhou Daming United Rubber Products, Ltd. · 2016
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K023405Trojan Mint Tingle Brand Latex CondomsArmkel, LLC · 2002 · cites it directly6descendants
- K103119Billy Boy Male Latex CondomSheila Pickering PHD · 2011 · 2 generations on5descendants
- K120394Lifestyles Zero Lubricated Latex CondomAnsell Heathcare Products, LLC · 2012 · 3 generations on1descendant
- K111093Billy Boy Male Latex CondomMapa GmbH · 2011 · 3 generations on1descendant
- K153016aoni Natural Rubber Latex CondomGuangzhou Daming United Rubber Products, Ltd. · 2016 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K890863 | Trojan for Women | Armkel, LLC | 1989 | — |
| 0 (this device) | K013433 | Trojan Passion Berry Gel | Armkel, LLC | 2002 | — |
| +1 | K023405 | Trojan Mint Tingle Brand Latex Condoms | Armkel, LLC | 2002 | — |
| +2 | K103119 | Billy Boy Male Latex Condom | Sheila Pickering PHD | 2011 | — |
| +3 | K120394 | Lifestyles Zero Lubricated Latex Condom | Ansell Heathcare Products, LLC | 2012 | 1 |
| +3 | K111093 | Billy Boy Male Latex Condom | Mapa GmbH | 2011 | — |
| +4 | K153016 | aoni Natural Rubber Latex Condom | Guangzhou Daming United Rubber Products, Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 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 NUC? 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 NUC device
- #1 K211998 Desnuda Reflectscore 18.6 · 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? (2)
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 |
|---|---|---|---|
| * | K890863 | Trojan for WomenSummary page 1…Classification Name: Patient Lubricant [21 CFR §880.6375] Predicate Device: HeR® Lubricating Jelly [Pre-1976 Amendments Device] TROJAN® FOR WOMEN Personal Lubricant [#K890863] Description of Device: The TROJAN® PASSION BERRY™ Gel personal Jubricant is formulated as a clear, high viscosity gel with a pi… | 1989 |
| * | — | HeR® Lubricating Jelly Named without a submission number |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023405 | Trojan Mint Tingle Brand Latex Condoms | 2002 | 6 |
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 NUC devicesNUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NUC
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NUC
221in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NUC
3in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NUC
13in 2025
MAUDE reports naming product code NUC, 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 | 5 | 150 | 0 | 0 |
| 2008 | 7 | 271 | 1 | 6 |
| 2009 | 2 | — | 1 | 13 |
| 2010 | 4 | 124 | 0 | 2 |
| 2011 | 2 | — | 0 | 3 |
| 2012 | 6 | 269 | 0 | 6 |
| 2013 | 11 | 205 | 3 | 5 |
| 2014 | 11 | 264 | 0 | 14 |
| 2015 | 21 | 251 | 0 | 8 |
| 2016 | 14 | 181 | 0 | 14 |
| 2017 | 14 | 175 | 0 | 19 |
| 2018 | 15 | 114 | 0 | 6 |
| 2019 | 13 | 150 | 0 | 8 |
| 2020 | 19 | 180 | 0 | 2 |
| 2021 | 20 | 143 | 0 | 7 |
| 2022 | 14 | 112 | 0 | 7 |
| 2023 | 13 | 159 | 0 | 15 |
| 2024 | 6 | 178 | 0 | 13 |
| 2025 | 11 | 221 | 0 | 13 |
| 2026 | 12 | 104 | 0 | — |
What is it indicated for?
The TROJAN® PASSION BERRY™ Gel patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device. The TROJAN® PASSION BERRY™ Gel is principally designed to help enhance the sexual experience by providing supplemental vaginal lubrication during sexual intercourse. The TROJAN® PASSION BERRY™ Gel may be used with condoms.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013433 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013433: Trojan Passion Berry Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013433
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026