510(k) · Cleared
ClearedTrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Church & Dwight Co., Inc. · NUC Lubricant, Personal
Cleared on Aug 1, 2018 as substantially equivalent to K141034 (Church & Dwight Co., Inc., 2014) after a 131-day review. Its family tree reaches back 6 generations to 1981. 1 later device descends from it.
- Decided
- Aug 1, 2018
- Review
- 131 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K810310 (1981). 11 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK810310 K-Y Lubricating JellyJohnson & Johnson Professionals, Inc. · 1981
- 5 generations backK935299 AstroglideBiofilm, Inc. · 1994
- 4 generations backK032124 Durex Play LubricantSsl Americas, Inc. · 2004
- 3 generations backK060098 Durex Play Temptations Assorted LubricantsSsl Americas, Inc. · 2006
- 2 generations backK122054 Lifestyles Natural Personal LubricantAnsell Healthcare Products, LLC · 2013
- 1 generation backK141034 Azul Personal LubricantChurch & Dwight Co., Inc. · 2014
- This deviceK180764 TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal…Church & Dwight Co., Inc. · 2018
- Descendant · cites it directly · 0 of its ownK202667 Personal Lubricant JellyNantong Health & Beyond Hygienic Products, Inc. · 2021
Most influential descendants
Showing 1 of 1 · See all- K202667Personal Lubricant JellyNantong Health & Beyond Hygienic Products, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K810310 | K-Y Lubricating Jelly | Johnson & Johnson Professionals, Inc. | 1981 | — |
| −5 | K935299 | Astroglide | Biofilm, Inc. | 1994 | — |
| −4 | K032124 | Durex Play Lubricant | Ssl Americas, Inc. | 2004 | — |
| −3 | K060098 | Durex Play Temptations Assorted Lubricants | Ssl Americas, Inc. | 2006 | — |
| −2 | K122054 | Lifestyles Natural Personal Lubricant | Ansell Healthcare Products, LLC | 2013 | — |
| −1 | K141034 | Azul Personal Lubricant | Church & Dwight Co., Inc. | 2014 | — |
| 0 (this device) | K180764 | TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) | Church & Dwight Co., Inc. | 2018 | — |
| +1 | K202667 | Personal Lubricant Jelly | Nantong Health & Beyond Hygienic Products, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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? (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 |
|---|---|---|---|
| * | K141034 | Azul Personal LubricantSummary page 4…sonal Lubricant Product Code: NUC (lubricant, personal) Classification: Class II, Condom (21 CFR § 884.5300) Predicate Device: K141034: TROJAN™ Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant)… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202667 | Personal Lubricant Jelly | 2021 | 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?
- The line of descent spans 37 years and passes through 5 companies; a new generation was cleared every 6.7 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K202667 (Nantong Health & Beyond Hygienic Products, Inc., 2021) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K141034.
How does its category compare?
All NUC devicesNUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
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?
Trojan™ Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) is a personal lubricant for penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane 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/K180764 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180764: TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180764
Report an extraction error
Are you the manufacturer?
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