510(k) · Cleared
ClearedDurex Play Warmer Lubricant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ssl Americas, Inc. · KMJ Lubricant, Patient
Cleared on Feb 23, 2005 as substantially equivalent to K955648 (Ortho Pharmaceutical Corp., 1996) and 1 other predicate after a 155-day review. Its family tree reaches back 2 generations to 1981. 24 later devices descend from it.
- Decided
- Feb 23, 2005
- Review
- 155 days
- Class
- Class I
- Product code
- KMJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K810310 (1981). 3 ancestors in all. 24 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK810310 K-Y Lubricating JellyJohnson & Johnson Professionals, Inc. · 1981
- 1 generation backK935299 AstroglideBiofilm, Inc. · 1994
- This deviceK042563 Durex Play Warmer LubricantSsl Americas, Inc. · 2005
- Descendant · cites it directly · 22 of its ownK060098 Durex Play Temptations Assorted LubricantsSsl Americas, Inc. · 2006
- Descendant · 2 generations on · 13 of its ownK122476 Lifestyles Smooth 2-in-1 Massage & LubricantAnsell Healthcare Products, LLC · 2013
- Descendant · 3 generations on · 7 of its ownK140590 Astroglide Sensual StrawberryBiofilm, Inc. · 2014
- Descendant · 2 generations on · 6 of its ownK122054 Lifestyles Natural Personal LubricantAnsell Healthcare Products, LLC · 2013
- Descendant · 4 generations on · 3 of its ownK172447 JO Gelato Flavored Personal LubricantsUnited Consortium · 2017
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K060098Durex Play Temptations Assorted LubricantsSsl Americas, Inc. · 2006 · cites it directly22descendants
- K122476Lifestyles Smooth 2-in-1 Massage & LubricantAnsell Healthcare Products, LLC · 2013 · 2 generations on13descendants
- K140590Astroglide Sensual StrawberryBiofilm, Inc. · 2014 · 3 generations on7descendants
- K122054Lifestyles Natural Personal LubricantAnsell Healthcare Products, LLC · 2013 · 2 generations on6descendants
- K172447JO Gelato Flavored Personal LubricantsUnited Consortium · 2017 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K810310 | K-Y Lubricating Jelly | Johnson & Johnson Professionals, Inc. | 1981 | — |
| −1 | K935299 | Astroglide | Biofilm, Inc. | 1994 | — |
| 0 (this device) | K042563 | Durex Play Warmer Lubricant | Ssl Americas, Inc. | 2005 | — |
| +1 | K060098 | Durex Play Temptations Assorted Lubricants | Ssl Americas, Inc. | 2006 | — |
| +2 | K122476 | Lifestyles Smooth 2-in-1 Massage & Lubricant | Ansell Healthcare Products, LLC | 2013 | — |
| +3 | K140590 | Astroglide Sensual Strawberry | Biofilm, Inc. | 2014 | — |
| +2 | K122054 | Lifestyles Natural Personal Lubricant | Ansell Healthcare Products, LLC | 2013 | — |
| +4 | K172447 | JO Gelato Flavored Personal Lubricants | United Consortium | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 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 KMJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K955648 | K-Y Personal LubricantSummary page 1…Trade Name: Durex Play WarmeriM Device Common Name: Personal lubricant Classification: Patient lubricant Section VIII.3 Predicate Devices K-Y Jelly Personal Lubricant (K955648) AstroGlide (K935299) Section VIII.4 Device Description Durex Play Warmer TM is a clear colorless personal lubricant composed of… | 1996 |
| * | K935299 | AstroglideSummary page 1…ay WarmeriM Device Common Name: Personal lubricant Classification: Patient lubricant Section VIII.3 Predicate Devices K-Y Jelly Personal Lubricant (K955648) AstroGlide (K935299) Section VIII.4 Device Description Durex Play Warmer TM is a clear colorless personal lubricant composed of Purified Water, Hydr… | 1994 |
What descends from it? (24)
See all 243 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 24 years and passes through 3 companies; a new generation was cleared every 12.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K060098 (Ssl Americas, Inc., 2006) has gone furthest, with 22 descendants of its own.
- 14 other devices also cite its predicate K955648.
How does its category compare?
All KMJ devicesKMJ Lubricant, Patient: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KMJ
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KMJ
141in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KMJ
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KMJ
1in 2025
MAUDE reports naming product code KMJ, 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 | 0 | — | 0 | 5 |
| 2008 | 3 | 86 | 0 | 3 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 1 | — | 1 | 1 |
| 2011 | 1 | — | 12 | 7 |
| 2012 | 3 | 141 | 0 | 2 |
| 2013 | 1 | — | 0 | 6 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 1 | — | 0 | 4 |
| 2016 | 0 | — | 1 | 5 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Durex Play TM Warmer TM is intended as a moisturizer for vaginal dryness and personal lubrication of the vaginal entry to enhance condom use and to facilitate ease and comfort during intimate sexual activity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042563 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042563: Durex Play Warmer Lubricant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042563
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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