510(k) · Cleared
ClearedPlay and Joy Water-Based Lubricant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovemed Bio-Tech Co., Ltd. · NUC Lubricant, Personal
Cleared on Jul 11, 2023 as substantially equivalent to K203654 (Solevy Co., LLC, 2021) after a 448-day review. Its family tree reaches back 6 generations to 1990.
- Decided
- Jul 11, 2023
- Review
- 448 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K903910 (1990). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK903910 Lubricating JellyLake Pharmaceutical, Inc. · 1990
- 5 generations backK982673 Just Between US, Personal Lubricant & CondomKey West Fragrance & Cosmetic · 1998
- 4 generations backK033776 Instead Intimate LubricantInstead, Inc. · 2004
- 3 generations backK051295 I-D GlideWestridge Laboratories, Inc. · 2006
- 2 generations backK150480 JO H20 Water Based Personal LubricantUnited Consortium, Inc. · 2015
- 1 generation backK203654 Solevy Co. LLC Water-Based Personal LubricantSolevy Co., LLC · 2021
- This deviceK221137 Play and Joy Water-Based LubricantInnovemed Bio-Tech Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K903910 | Lubricating Jelly | Lake Pharmaceutical, Inc. | 1990 | — |
| −5 | K982673 | Just Between US, Personal Lubricant & Condom | Key West Fragrance & Cosmetic | 1998 | — |
| −4 | K033776 | Instead Intimate Lubricant | Instead, Inc. | 2004 | — |
| −3 | K051295 | I-D Glide | Westridge Laboratories, Inc. | 2006 | — |
| −2 | K150480 | JO H20 Water Based Personal Lubricant | United Consortium, Inc. | 2015 | — |
| −1 | K203654 | Solevy Co. LLC Water-Based Personal Lubricant | Solevy Co., LLC | 2021 | — |
| 0 (this device) | K221137 | Play and Joy Water-Based Lubricant | Innovemed Bio-Tech Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K203654 | Solevy Co. LLC Water-Based Personal LubricantSummary page 4…Condom Product Code: NUC (lubricant, personal) Device Class: Class II 5 Predicate Device Information: K203654, Solvey Co. LLC Water-Based Lubricant The predicate device has not been subject to a design-related recall. 6 De… | 2021 |
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 33 years and passes through 7 companies; a new generation was cleared every 5.8 years on median.
- None of the 10 ancestors has a recall.
How does its category compare?
All NUC devicesNUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
Play and Joy Water-Based Lubricant is a water-based personal lubricant, 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 as stated in the FDA summary.
https://510kreport.com/device/K221137 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221137: Play and Joy Water-Based Lubricant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221137
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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