510(k) · Cleared
ClearedAzul 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 Jul 21, 2014 as substantially equivalent to K122054 (Ansell Healthcare Products, LLC, 2013) and 1 other predicate after a 90-day review. Its family tree reaches back 5 generations to 1981. 3 later devices descend from it.
- Decided
- Jul 21, 2014
- Review
- 90 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K810310 (1981). 10 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK810310 K-Y Lubricating JellyJohnson & Johnson Professionals, Inc. · 1981
- 4 generations backK935299 AstroglideBiofilm, Inc. · 1994
- 3 generations backK032124 Durex Play LubricantSsl Americas, Inc. · 2004
- 2 generations backK060098 Durex Play Temptations Assorted LubricantsSsl Americas, Inc. · 2006
- 1 generation backK122054 Lifestyles Natural Personal LubricantAnsell Healthcare Products, LLC · 2013
- This deviceK141034 Azul Personal LubricantChurch & Dwight Co., Inc. · 2014
- Descendant · cites it directly · 1 of its ownK180764 TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal…Church & Dwight Co., Inc. · 2018
- Descendant · cites it directly · 0 of its ownK253989 HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm…Maxigen Biotech, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK202667 Personal Lubricant JellyNantong Health & Beyond Hygienic Products, Inc. · 2021
Most influential descendants
Showing 3 of 3 · See all- K180764TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant)Church & Dwight Co., Inc. · 2018 · cites it directly1descendant
- K253989HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based…Maxigen Biotech, Inc. · 2026 · cites it directly0descendants
- K202667Personal Lubricant JellyNantong Health & Beyond Hygienic Products, Inc. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K810310 | K-Y Lubricating Jelly | Johnson & Johnson Professionals, Inc. | 1981 | — |
| −4 | K935299 | Astroglide | Biofilm, Inc. | 1994 | — |
| −3 | K032124 | Durex Play Lubricant | Ssl Americas, Inc. | 2004 | — |
| −2 | K060098 | Durex Play Temptations Assorted Lubricants | Ssl Americas, Inc. | 2006 | — |
| −1 | K122054 | Lifestyles Natural Personal Lubricant | Ansell Healthcare Products, LLC | 2013 | — |
| 0 (this device) | K141034 | Azul Personal Lubricant | Church & Dwight Co., Inc. | 2014 | — |
| +1 | K180764 | TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) | Church & Dwight Co., Inc. | 2018 | — |
| +1 | K253989 | HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water… | Maxigen Biotech, Inc. | 2026 | — |
| +2 | 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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K122054 | Lifestyles Natural Personal LubricantSummary page 1…Product Code: NUC - Condom (21 CFR § 884.5300) Classification: Class 11 Predicate Devices: Lifestyles Natural (K 122054) Aloe Cadabra Lubricant (K 124044) Device Description: The Aztil Personal Lubr… | 2013 |
| * | K124044 | Aloe Cadabra Lubricant, Aloe Cadabra Flavored/Scented LubricantsSummary page 1…Classification: Class 11 Predicate Devices: Lifestyles Natural (K 122054) Aloe Cadabra Lubricant (K 124044) Device Description: The Aztil Personal Lubricant is a hydrous, clear water-based personal… | 2013 |
What descends from it? (3)
2 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?
- The line of descent spans 33 years and passes through 5 companies; a new generation was cleared every 6.7 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K180764 (Church & Dwight Co., Inc., 2018) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K122054.
How does its category compare?
All NUC devicesNUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
Azul 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 as stated in the FDA summary.
https://510kreport.com/device/K141034 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141034: Azul Personal Lubricant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141034
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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