510(k) · Cleared
ClearedDurex Play Tingling Lubricant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ssl Americas, Inc. · NUC Lubricant, Personal
Cleared on Apr 8, 2005 as substantially equivalent to K955648 (Ortho Pharmaceutical Corp., 1996) and 3 other predicates after a 163-day review. Its family tree reaches back 3 generations to 1981.
- Decided
- Apr 8, 2005
- Review
- 163 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.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K810310 | K-Y Lubricating Jelly | Johnson & Johnson Professionals, Inc. | 1981 | — |
| −2 | K935299 | Astroglide | Biofilm, Inc. | 1994 | — |
| −1 | K032124 | Durex Play Lubricant | Ssl Americas, Inc. | 2004 | — |
| 0 (this device) | K042958 | Durex Play Tingling Lubricant | Ssl Americas, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1996 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K955648 | K-Y Personal LubricantSummary page 1…Tingling lubricant. Device common name: Personal Lubricant Classification: Patient Lubricant Section VIII.3 Predicate devices. K-Y Jelly Personal lubricant (K955648) Astroglyde (K935299) Durex Spearmint scented condoms (K900679) Durex Play T M Personal Lubricant (K032124) Section… | 1996 |
| * | K935299 | AstroglideSummary page 1…evice common name: Personal Lubricant Classification: Patient Lubricant Section VIII.3 Predicate devices. K-Y Jelly Personal lubricant (K955648) Astroglyde (K935299) Durex Spearmint scented condoms (K900679) Durex Play T M Personal Lubricant (K032124) Section VIII.4 Device Descriptio… | 1994 |
| * | K900679 | Mint Scented CondomsSummary page 1…sification: Patient Lubricant Section VIII.3 Predicate devices. K-Y Jelly Personal lubricant (K955648) Astroglyde (K935299) Durex Spearmint scented condoms (K900679) Durex Play T M Personal Lubricant (K032124) Section VIII.4 Device Description Durex PlayTM Tingling personal Lubricant… | 1990 |
| * | K032124 | Durex Play LubricantSummary page 1…3 Predicate devices. K-Y Jelly Personal lubricant (K955648) Astroglyde (K935299) Durex Spearmint scented condoms (K900679) Durex Play T M Personal Lubricant (K032124) Section VIII.4 Device Description Durex PlayTM Tingling personal Lubricant is a clear, colorless, spearmint scented pe… | 2004 |
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 24 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 devicesNUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Durex Play TM Tingling 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042958 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042958: Durex Play Tingling Lubricant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042958
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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