510(k) · Cleared
ClearedJO Gelato Flavored Personal Lubricants
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United Consortium · NUC Lubricant, Personal
Cleared on Oct 31, 2017 as substantially equivalent to K140590 (Biofilm, Inc., 2014) after a 78-day review. Its family tree reaches back 6 generations to 1981. 3 later devices descend from it.
- Decided
- Oct 31, 2017
- Review
- 78 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K810310 (1981). 8 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK810310 K-Y Lubricating JellyJohnson & Johnson Professionals, Inc. · 1981
- 5 generations backK935299 AstroglideBiofilm, Inc. · 1994
- 4 generations backK032124 Durex Play LubricantSsl Americas, Inc. · 2004
- 3 generations backK060098 Durex Play Temptations Assorted LubricantsSsl Americas, Inc. · 2006
- 2 generations backK122476 Lifestyles Smooth 2-in-1 Massage & LubricantAnsell Healthcare Products, LLC · 2013
- 1 generation backK140590 Astroglide Sensual StrawberryBiofilm, Inc. · 2014
- This deviceK172447 JO Gelato Flavored Personal LubricantsUnited Consortium · 2017
- Descendant · cites it directly · 0 of its ownK221829 Wet Flavored Personal LubricantsTrigg Laboratories, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK192204 Sensuva Strawberry Personal Lubricant, Sensuva Apple Candy Personal…Valencia Naturals, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK182105 JO Naturalove Personal Lubricant, JO Naturalove Strawberry Fields…United Consortium · 2018
Most influential descendants
Showing 3 of 3 · See all- K221829Wet Flavored Personal LubricantsTrigg Laboratories, Inc. · 2022 · cites it directly0descendants
- K192204Sensuva Strawberry Personal Lubricant, Sensuva Apple Candy Personal Lubricant, Sensuva…Valencia Naturals, Inc. · 2019 · cites it directly0descendants
- K182105JO Naturalove Personal Lubricant, JO Naturalove Strawberry Fields Flavored Personal…United Consortium · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K810310 | K-Y Lubricating Jelly | Johnson & Johnson Professionals, Inc. | 1981 | — |
| −5 | K935299 | Astroglide | Biofilm, Inc. | 1994 | — |
| −4 | K032124 | Durex Play Lubricant | Ssl Americas, Inc. | 2004 | — |
| −3 | 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 | K140590 | Astroglide Sensual Strawberry | Biofilm, Inc. | 2014 | — |
| 0 (this device) | K172447 | JO Gelato Flavored Personal Lubricants | United Consortium | 2017 | — |
| +1 | K221829 | Wet Flavored Personal Lubricants | Trigg Laboratories, Inc. | 2022 | — |
| +1 | K192204 | Sensuva Strawberry Personal Lubricant, Sensuva Apple Candy Personal Lubricant… | Valencia Naturals, Inc. | 2019 | — |
| +1 | 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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 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 |
|---|---|---|---|
| * | K140590 | Astroglide Sensual StrawberrySummary page 4…Device Class: Class II Predicate Device: Product Name: Astroglide Sensual Strawberry 510(k) Number: K140590 Manufacturer: BioFilm, Inc. Product Code: NUC… | 2014 |
What descends from it? (3)
3 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 36 years and passes through 5 companies; a new generation was cleared every 6.7 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K221829 (Trigg Laboratories, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K140590.
How does its category compare?
All NUC devicesNUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
JO Gelato Flavored Personal Lubricants are water-based personal lubricants for penile and/or vaginal application,
intended to lubricate and moisturize, 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, polyurethane and polyisoprene 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/K172447 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172447: JO Gelato Flavored Personal Lubricants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172447
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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