510(k) · Cleared
ClearedAstroglide Sensual Strawberry
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biofilm, Inc. · NUC Lubricant, Personal
Cleared on Oct 30, 2014 as substantially equivalent to K122476 (Ansell Healthcare Products, LLC, 2013) after a 237-day review. Its family tree reaches back 5 generations to 1981. 7 later devices descend from it.
- Decided
- Oct 30, 2014
- Review
- 237 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K810310 (1981). 7 ancestors in all. 7 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK810310 K-Y Lubricating JellyJohnson & Johnson Professionals, Inc. · 1981
- 4 generations backK935299 AstroglideBiofilm, Inc. · 1994
- 3 generations backK032124 Durex Play LubricantSsl Americas, Inc. · 2004
- 2 generations backK060098 Durex Play Temptations Assorted LubricantsSsl Americas, Inc. · 2006
- 1 generation backK122476 Lifestyles Smooth 2-in-1 Massage & LubricantAnsell Healthcare Products, LLC · 2013
- This deviceK140590 Astroglide Sensual StrawberryBiofilm, Inc. · 2014
- Descendant · cites it directly · 3 of its ownK172447 JO Gelato Flavored Personal LubricantsUnited Consortium · 2017
- Descendant · 2 generations on · 0 of its ownK221829 Wet Flavored Personal LubricantsTrigg Laboratories, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK192204 Sensuva Strawberry Personal Lubricant, Sensuva Apple Candy Personal…Valencia Naturals, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK182100 Smile Makers Personal LubricantLfbeauty (Thailand) Limited · 2019
- Descendant · 2 generations on · 0 of its ownK182105 JO Naturalove Personal Lubricant, JO Naturalove Strawberry Fields…United Consortium · 2018
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K172447JO Gelato Flavored Personal LubricantsUnited Consortium · 2017 · cites it directly3descendants
- K221829Wet Flavored Personal LubricantsTrigg Laboratories, Inc. · 2022 · 2 generations on0descendants
- K192204Sensuva Strawberry Personal Lubricant, Sensuva Apple Candy Personal Lubricant, Sensuva…Valencia Naturals, Inc. · 2019 · 2 generations on0descendants
- K182100Smile Makers Personal LubricantLfbeauty (Thailand) Limited · 2019 · cites it directly0descendants
- K182105JO Naturalove Personal Lubricant, JO Naturalove Strawberry Fields Flavored Personal…United Consortium · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K810310 | K-Y Lubricating Jelly | Johnson & Johnson Professionals, Inc. | 1981 | — |
| −4 | K935299 | Astroglide | Biofilm, Inc. | 1994 | — |
| −3 | K032124 | Durex Play Lubricant | Ssl Americas, Inc. | 2004 | — |
| −2 | K060098 | Durex Play Temptations Assorted Lubricants | Ssl Americas, Inc. | 2006 | — |
| −1 | K122476 | Lifestyles Smooth 2-in-1 Massage & Lubricant | Ansell Healthcare Products, LLC | 2013 | — |
| 0 (this device) | K140590 | Astroglide Sensual Strawberry | Biofilm, Inc. | 2014 | — |
| +1 | K172447 | JO Gelato Flavored Personal Lubricants | United Consortium | 2017 | — |
| +2 | K221829 | Wet Flavored Personal Lubricants | Trigg Laboratories, Inc. | 2022 | — |
| +2 | K192204 | Sensuva Strawberry Personal Lubricant, Sensuva Apple Candy Personal Lubricant… | Valencia Naturals, Inc. | 2019 | — |
| +1 | K182100 | Smile Makers Personal Lubricant | Lfbeauty (Thailand) Limited | 2019 | — |
| +2 | K182105 | JO Naturalove Personal Lubricant, JO Naturalove Strawberry Fields Flavored… | United Consortium | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2022 | 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? (1)
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 |
|---|---|---|---|
| * | K122476 | Lifestyles Smooth 2-in-1 Massage & LubricantSummary page 4…stroglide Sensual Strawberry Common Name: Personal Lubricant Classification Name: Condom (21 CFR 884.5300, Product code: NUC, Class II). Predicate Device: 510(k) Number K122476, Lifestyles® Smooth™ 2-in-1 Massage and Lubricant, Ansell Healthcare Products, LLC; Class II, Product Code: NUC Description of D… | 2013 |
What descends from it? (7)
4 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 33 years and passes through 4 companies; a new generation was cleared every 6.7 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K172447 (United Consortium, 2017) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K122476.
How does its category compare?
All NUC devicesNUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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?
Astroglide Sensual Strawberry is a personal lubricant, for penile and/or vaginal application, intended to moisturize and
lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This
product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K140590 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140590: Astroglide Sensual Strawberry.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140590
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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