510(k) · Cleared
ClearedMedley
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Good Clean Love, Inc. · NUC Lubricant, Personal
Cleared on Nov 18, 2021 as substantially equivalent to K191480 (Trigg Laboratories, Inc. D/B/A Wet International, 2019) after a 143-day review. Its family tree reaches back 5 generations to 1989. 1 later device descends from it.
- Decided
- Nov 18, 2021
- Review
- 143 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K890863 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK890863 Trojan for WomenArmkel, LLC · 1989
- 4 generations backK013614 Trojan Crystal Clear LiquidArmkel, LLC · 2002
- 3 generations backK120751 Nirvana B Personal LubricantChurch & Dwight Co., Inc. · 2012
- 2 generations backK181408 JO Classic Hybrid Personal LubricantUnited Consortium · 2018
- 1 generation backK191480 Wet Water Based Personal Lubricant (additionally, branded as WET…Trigg Laboratories, Inc. D/B/A Wet International · 2019
- This deviceK212000 MedleyGood Clean Love, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK222567 Playground For All Love SeshPlayground For All · 2023
Most influential descendants
Showing 1 of 1 · See all- K222567Playground For All Love SeshPlayground For All · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K890863 | Trojan for Women | Armkel, LLC | 1989 | — |
| −4 | K013614 | Trojan Crystal Clear Liquid | Armkel, LLC | 2002 | — |
| −3 | K120751 | Nirvana B Personal Lubricant | Church & Dwight Co., Inc. | 2012 | — |
| −2 | K181408 | JO Classic Hybrid Personal Lubricant | United Consortium | 2018 | — |
| −1 | K191480 | Wet Water Based Personal Lubricant (additionally, branded as WET Platinum… | Trigg Laboratories, Inc. D/B/A Wet International | 2019 | — |
| 0 (this device) | K212000 | Medley | Good Clean Love, Inc. | 2021 | — |
| +1 | K222567 | Playground For All Love Sesh | Playground For All | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K191480 | Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite…Summary page 4…4.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC (lubricant, personal) Predicate Device: K191480, WET Water Based Personal Lubricant (additionally branded as WET Platinum Houston, Elite Water-Base… | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222567 | Playground For All Love Sesh | 2023 | 0 |
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 32 years and passes through 5 companies; a new generation was cleared every 5.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K222567 (Playground For All, 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K191480.
How does its category compare?
All NUC devicesNUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
Medley 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212000 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212000: Medley.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212000
Report an extraction error
Are you the manufacturer?
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