510(k) Report

510(k) · Cleared

Cleared

Durex Play Temptations Assorted Lubricants

K060098510(k) TraditionalCleared Jun 8, 2006146-day reviewClass II21 CFR 884.5300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ssl Americas, Inc. · NUC Lubricant, Personal

Cleared on Jun 8, 2006 as substantially equivalent to K955648 (Ortho Pharmaceutical Corp., 1996) and 3 other predicates after a 146-day review. Its family tree reaches back 3 generations to 1981. 22 later devices descend from it.

Decided
Jun 8, 2006
Review
146 days
Class
Class II
Product code
NUC
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K810310 (1981). 5 ancestors in all. 22 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor1996: 1 other ancestor2008: 1 descendant cleared2013: 3 descendants cleared2022: 3 descendants cleared2014: 2 descendants cleared2015: 1 descendant cleared2016: 1 descendant cleared2019: 2 descendants cleared2018: 3 descendants cleared2017: 2 descendants cleared2026: 1 descendant cleared2023: 1 descendant cleared2021: 2 descendants clearedReference device: K042958 · Durex Play Tingling Lubricant · Ssl Americas, Inc. · 2005K810310 · K-Y Lubricating Jelly · Johnson & Johnson Professionals, Inc. · 1981K935299 · Astroglide · Biofilm, Inc. · 1994K032124 · Durex Play Lubricant · Ssl Americas, Inc. · 200419801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 6 descendants3 generations forward: 9 descendants4 generations forward: 4 descendants K032124 · Durex Play Lubricant · Ssl Americas, Inc. · 2004K935299 · Astroglide · Biofilm, Inc. · 1994K810310 · K-Y Lubricating Jelly · Johnson & Johnson Professionals, Inc. · 19810
  1. Root · 3 generations backK810310 K-Y Lubricating JellyJohnson & Johnson Professionals, Inc. · 1981
  2. 2 generations backK935299 AstroglideBiofilm, Inc. · 1994
  3. 1 generation backK032124 Durex Play LubricantSsl Americas, Inc. · 2004
  4. This deviceK060098 Durex Play Temptations Assorted LubricantsSsl Americas, Inc. · 2006
  5. Descendant · cites it directly · 13 of its ownK122476 Lifestyles Smooth 2-in-1 Massage & LubricantAnsell Healthcare Products, LLC · 2013
  6. Descendant · 2 generations on · 7 of its ownK140590 Astroglide Sensual StrawberryBiofilm, Inc. · 2014
  7. Descendant · cites it directly · 6 of its ownK122054 Lifestyles Natural Personal LubricantAnsell Healthcare Products, LLC · 2013
  8. Descendant · 3 generations on · 3 of its ownK172447 JO Gelato Flavored Personal LubricantsUnited Consortium · 2017
  9. Descendant · 2 generations on · 3 of its ownK141034 Azul Personal LubricantChurch & Dwight Co., Inc. · 2014

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2008: 12013: 32014: 22015: 12016: 12017: 22018: 32019: 22021: 22022: 32023: 12026: 1
2008high 3 (2013) · low 0 (2009)2026

Most influential descendants

Showing 5 of 22 · See all
  • K122476Lifestyles Smooth 2-in-1 Massage & LubricantAnsell Healthcare Products, LLC · 2013 · cites it directly13descendants
  • K140590Astroglide Sensual StrawberryBiofilm, Inc. · 2014 · 2 generations on7descendants
  • K122054Lifestyles Natural Personal LubricantAnsell Healthcare Products, LLC · 2013 · cites it directly6descendants
  • K172447JO Gelato Flavored Personal LubricantsUnited Consortium · 2017 · 3 generations on3descendants
  • K141034Azul Personal LubricantChurch & Dwight Co., Inc. · 2014 · 2 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K810310K-Y Lubricating JellyJohnson & Johnson Professionals, Inc.1981—
−2K935299AstroglideBiofilm, Inc.1994—
−1K032124Durex Play LubricantSsl Americas, Inc.2004—
0 (this device)K060098Durex Play Temptations Assorted LubricantsSsl Americas, Inc.2006—
+1K122476Lifestyles Smooth 2-in-1 Massage & LubricantAnsell Healthcare Products, LLC2013—
+2K140590Astroglide Sensual StrawberryBiofilm, Inc.2014—
+1K122054Lifestyles Natural Personal LubricantAnsell Healthcare Products, LLC2013—
+3K172447JO Gelato Flavored Personal LubricantsUnited Consortium2017—
+2K141034Azul Personal LubricantChurch & Dwight Co., Inc.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201330
201420
201510
201610
201720
201830
201920
202120
202230
202310
202610
FIG. 1 — Lineage of K060098, 1981–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K211998 Desnuda Reflectscore 18.6 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K955648K-Y Personal Lubricant
Summary page 1
…mptations Assorted lubricants. Device common name: Personal Lubricant Classification: Patient Lubricant Section VIII.3 Predicate devices. K-Y Jelly Personal lubricant (K955648) Astroglide (K935299) Durex PlayT1' Warmer lubricant (K042563) Durex Play~m Personal Lubricant (K032124) Section VIII.4 Device…
Ortho Pharmaceutical Corp.1996—
*K935299Astroglide
Summary page 1
…bricants. Device common name: Personal Lubricant Classification: Patient Lubricant Section VIII.3 Predicate devices. K-Y Jelly Personal lubricant (K955648) Astroglide (K935299) Durex PlayT1' Warmer lubricant (K042563) Durex Play~m Personal Lubricant (K032124) Section VIII.4 Device Description Durex Pla…
Biofilm, Inc.1994—
*K042563Durex Play Warmer Lubricant
Summary page 1
…bricant Classification: Patient Lubricant Section VIII.3 Predicate devices. K-Y Jelly Personal lubricant (K955648) Astroglide (K935299) Durex PlayT1' Warmer lubricant (K042563) Durex Play~m Personal Lubricant (K032124) Section VIII.4 Device Description Durex Play~m Temptations Assorted personal lubrica…
Ssl Americas, Inc.2005—
*K032124Durex Play Lubricant
Summary page 1
…Section VIII.3 Predicate devices. K-Y Jelly Personal lubricant (K955648) Astroglide (K935299) Durex PlayT1' Warmer lubricant (K042563) Durex Play~m Personal Lubricant (K032124) Section VIII.4 Device Description Durex Play~m Temptations Assorted personal lubricants are clear, colorless, water soluble pe…
Ssl Americas, Inc.2004—
†K042958Durex Play Tingling LubricantSsl Americas, Inc.2005—

Also cleared against K955648: 14 other devices →

What descends from it? (22)

See all 22

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K122476Lifestyles Smooth 2-in-1 Massage & LubricantAnsell Healthcare Products, LLC201313
K122054Lifestyles Natural Personal LubricantAnsell Healthcare Products, LLC20136
K071626Durex Play Soft & Sensual LubricantSsl Americas20080

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 25 years and passes through 3 companies; a new generation was cleared every 9.9 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K122476 (Ansell Healthcare Products, LLC, 2013) has gone furthest, with 13 descendants of its own.
  • 14 other devices also cite its predicate K955648.

How does its category compare?

All NUC devices

NUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NUC

11in 2025

2007: 52008: 72009: 22010: 42011: 22012: 62013: 112014: 112015: 212016: 142017: 142018: 152019: 132020: 192021: 202022: 142023: 132024: 62025: 112026 (partial year): 12
2007high 21 (2015) · low 2 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NUC

221in 2025

2007: 150 days median2008: 271 days median2010: 124 days median2012: 269 days median2013: 205 days median2014: 264 days median2015: 251 days median2016: 181 days median2017: 175 days median2018: 114 days median2019: 150 days median2020: 180 days median2021: 143 days median2022: 112 days median2023: 159 days median2024: 178 days median2025: 221 days median2026 (partial year): 104 days median
2007high 271 (2008) · low 112 (2022)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NUC

3in 2013

2008: 12009: 12013: 3
2007high 3 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NUC

13in 2025

2008: 62009: 132010: 22011: 32012: 62013: 52014: 142015: 82016: 142017: 192018: 62019: 82020: 22021: 72022: 72023: 152024: 132025: 13
2007high 19 (2017) · low 0 (2007)2025

MAUDE reports naming product code NUC, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007515000
2008727116
20092—113
2010412402
20112—03
2012626906
20131120535
201411264014
20152125108
201614181014
201714175019
20181511406
20191315008
20201918002
20212014307
20221411207
202313159015
20246178013
202511221013
2026121040—

What is it indicated for?

Durex Temptations Assorted Lubricants are 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.

Also cleared against K955648

14 other devices cite the same predicate.

  • K151884K-Y Marilyn Pleasure GelReckitt Benckiser, LLC · 2016
  • K110325Aqua LubeMayer Laboratories, Inc. · 2011
  • K091554Pharmapac Personal LubricantPharmapac, LLC · 2009
  • K070587Elegance Woman's LubricantJulie Williams, Pa-C · 2008
  • K071626Durex Play Soft & Sensual LubricantSsl Americas · 2008
  • K063385Durex Play Massage Gel LubricantSsl Americas, Inc. · 2008

More from Ssl Americas, Inc.

10 FDA decisions under this applicant name. See the company

  • K072169Durex Synthetic Polyisoprene Male CondomSsl Americas, Inc. · 20084 recalls
  • K063385Durex Play Massage Gel LubricantSsl Americas, Inc. · 2008
  • K042958Durex Play Tingling LubricantSsl Americas, Inc. · 2005
  • K042470Durex Spearmint Scented Lubricated Latex Condom (Durex 'Tingling Pleasure' CondomSsl Americas, Inc. · 2005
  • K042563Durex Play Warmer LubricantSsl Americas, Inc. · 2005

Recent decisions in NUC

The NUC category page

  • K260117EverslideSpecial Situations, LLC · 2026
  • K253989HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU…Maxigen Biotech, Inc. · 2026
  • K261905BUM OilBumlicious, LLC (DBA “Bumlicious”) · 2026
  • K261177PINKSLIP Water-Based Personal Lubricant and MoisturizerPinkslip, LLC · 2026
  • K261909Plum Vagiceuticals™ Vaginal Moisturizing SuppositoriesPCCA, Inc. · 2026

https://510kreport.com/device/K060098 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060098: Durex Play Temptations Assorted Lubricants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060098

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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