510(k) Report

510(k) · Cleared

Cleared

Durex Play Massage Gel Lubricant

K063385510(k) TraditionalCleared Mar 10, 2008488-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 Mar 10, 2008 as substantially equivalent to K955648 (Ortho Pharmaceutical Corp., 1996) and 3 other predicates after a 488-day review. Its family tree reaches back 3 generations to 1981.

Decided
Mar 10, 2008
Review
488 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. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2005: 1 other ancestor1996: 1 other ancestorK810310 · K-Y Lubricating Jelly · Johnson & Johnson Professionals, Inc. · 1981K935299 · Astroglide · Biofilm, Inc. · 1994K032124 · Durex Play Lubricant · Ssl Americas, Inc. · 20041980198519901995200020052010
Other ancestors, by generation 1 generation back: 2 other ancestors 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 deviceK063385 Durex Play Massage Gel LubricantSsl Americas, Inc. · 2008
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)K063385Durex Play Massage Gel LubricantSsl Americas, Inc.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
200510
FIG. 1 — Lineage of K063385, 1981–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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
…ame: Durex PlayTM Massage gel Device common name: Personal Lubricant Classification: Patient Lubricant Section VIII.3 Predicate devices. K-Y Jelly Personal lubricant (K955648) Astroglide (K935299) Durex Play T M Warmer lubricant (K042563) Durex Play T M Personal Lubricant (K032124) Section VIII.4 Devi…
Ortho Pharmaceutical Corp.1996—
*K935299Astroglide
Summary page 1
…sage gel Device common name: Personal Lubricant Classification: Patient Lubricant Section VIII.3 Predicate devices. K-Y Jelly Personal lubricant (K955648) Astroglide (K935299) Durex Play T M Warmer lubricant (K042563) Durex Play T M Personal Lubricant (K032124) Section VIII.4 Device Description Durex…
Biofilm, Inc.1994—
*K042563Durex Play Warmer Lubricant
Summary page 1
…icant Classification: Patient Lubricant Section VIII.3 Predicate devices. K-Y Jelly Personal lubricant (K955648) Astroglide (K935299) Durex Play T M Warmer lubricant (K042563) Durex Play T M Personal Lubricant (K032124) Section VIII.4 Device Description Durex PlayTM Massage gel personal lubricant is…
Ssl Americas, Inc.2005—
*K032124Durex Play Lubricant
Summary page 1
…ction VIII.3 Predicate devices. K-Y Jelly Personal lubricant (K955648) Astroglide (K935299) Durex Play T M Warmer lubricant (K042563) Durex Play T M Personal Lubricant (K032124) Section VIII.4 Device Description Durex PlayTM Massage gel personal lubricant is a clear, colorless, water soluble personal l…
Ssl Americas, Inc.2004—

Also cleared against K955648: 14 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 27 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.
  • 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. 2008, this device’s year, is highlighted.

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 PlayTMMassage gel lubricant 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.

This lubricant has been shown to be compatible only with condoms made of natural rubber latex and synthetic polyisoprene.

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
  • K061466IntimolDlc Laboratories, Inc. · 2006

More from Ssl Americas, Inc.

10 FDA decisions under this applicant name. See the company

  • K072169Durex Synthetic Polyisoprene Male CondomSsl Americas, Inc. · 20084 recalls
  • K060098Durex Play Temptations Assorted LubricantsSsl Americas, Inc. · 2006
  • 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/K063385 · printed Nov 6, 2026

Cite this page

510(k) Report. “K063385: Durex Play Massage Gel Lubricant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063385

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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