510(k) · Cleared
ClearedDurex Play Lubricant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ssl Americas, Inc. · HIS Condom
Cleared on Jan 16, 2004 as substantially equivalent to K955648 (Ortho Pharmaceutical Corp., 1996) and 1 other predicate after a 190-day review. Its family tree reaches back 2 generations to 1981. 40 later devices descend from it.
- Decided
- Jan 16, 2004
- Review
- 190 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K810310 (1981). 3 ancestors in all. 40 later devices descend from it, 7 citing it directly.
- Root · 2 generations backK810310 K-Y Lubricating JellyJohnson & Johnson Professionals, Inc. · 1981
- 1 generation backK935299 AstroglideBiofilm, Inc. · 1994
- This deviceK032124 Durex Play LubricantSsl Americas, Inc. · 2004
- 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 · cites it directly · 11 of its ownK070587 Elegance Woman's LubricantJulie Williams, Pa-C · 2008
- Descendant · 2 generations on · 9 of its ownK150883 HyaloGYN Vaginal Hydrating GelFidia Farmaceutici S.P.A. · 2015
- Descendant · 3 generations on · 7 of its ownK140590 Astroglide Sensual StrawberryBiofilm, Inc. · 2014
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · 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
- K070587Elegance Woman's LubricantJulie Williams, Pa-C · 2008 · cites it directly11descendants
- K150883HyaloGYN Vaginal Hydrating GelFidia Farmaceutici S.P.A. · 2015 · 2 generations on9descendants
- K140590Astroglide Sensual StrawberryBiofilm, Inc. · 2014 · 3 generations on7descendants
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) | K032124 | Durex Play Lubricant | Ssl Americas, Inc. | 2004 | — |
| +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 | — |
| +1 | K070587 | Elegance Woman's Lubricant | Julie Williams, Pa-C | 2008 | — |
| +2 | K150883 | HyaloGYN Vaginal Hydrating Gel | Fidia Farmaceutici S.P.A. | 2015 | — |
| +3 | K140590 | Astroglide Sensual Strawberry | Biofilm, Inc. | 2014 | — |
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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 5 | 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 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? (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…Device Common Namb: Personal lubricant Classification: Patient lubricant Section VIII.3 Predicate Devices K-Y Jelly Personal Lubricant (K955648) AstroGlide (K935299) Section VIII.4 Device Description Durex PlayTm is a clear colorless personal lu… | 1996 |
| * | K935299 | AstroglideSummary page 1…onal lubricant Classification: Patient lubricant Section VIII.3 Predicate Devices K-Y Jelly Personal Lubricant (K955648) AstroGlide (K935299) Section VIII.4 Device Description Durex PlayTm is a clear colorless personal lubricant composed of purified… | 1994 |
What descends from it? (40)
See all 407 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060098 | Durex Play Temptations Assorted Lubricants | 2006 | 22 |
| K070587 | Elegance Woman's Lubricant | 2008 | 11 |
| K120650 | Poise Personal Lubricant | 2012 | 1 |
| K072236 | Durex Play Tingling Aqueous Based Lubricant | 2008 | 0 |
| K071626 | Durex Play Soft & Sensual Lubricant | 2008 | 0 |
| K063385 | Durex Play Massage Gel Lubricant | 2008 | 0 |
| K042958 | Durex Play Tingling Lubricant | 2005 | 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 23 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 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 | — |
What is it indicated for?
Durex PlayTM 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/K032124 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032124: Durex Play Lubricant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032124
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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