510(k) · Cleared
ClearedPremium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CC Wellness, LLC · NUC Lubricant, Personal
Cleared on May 22, 2020 as substantially equivalent to K132954 (United Consortium, 2014) after an 87-day review. Its family tree reaches back 2 generations to 2013.
- Decided
- May 22, 2020
- Review
- 87 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K122477 (2013). No later device cites it as a predicate yet.
- Root · 2 generations backK122477 Lifestyles Luxe Premium Personal LubricantAnsell Healthcare Products, LLC · 2013
- 1 generation backK132954 JO Premium Personal LubricantUnited Consortium · 2014
- This deviceK200457 Premium Warming Personal Lubricant, Premium Anal Warming Lubricant…CC Wellness, LLC · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K122477 | Lifestyles Luxe Premium Personal Lubricant | Ansell Healthcare Products, LLC | 2013 | — |
| −1 | K132954 | JO Premium Personal Lubricant | United Consortium | 2014 | — |
| 0 (this device) | K200457 | Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One… | CC Wellness, LLC | 2020 | — |
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 |
|---|---|---|---|
| * | K132954 | JO Premium Personal LubricantSummary page 4…e Class: Class II Predicate Device: Product Name: JO Premium Personal Lubricant 510(k) Number: K132954 Manufacturer: United Consortium Product Code: NUC… | 2014 |
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 7 years and passes through 3 companies; a new generation was cleared every 5.9 years on median.
- None of the 2 ancestors has a recall.
- 3 other devices also cite its predicate K132954.
How does its category compare?
All NUC devicesNUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
Premium Warming Personal Lubricant, Premium Anal Warming Lubricant and All-In-One Warming are personal lubricants for penile, anal 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. These products are compatible with natural rubber latex, polyisoprene and polyurethane condoms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200457 · printed Nov 4, 2026
Cite this page
510(k) Report. “K200457: Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K200457
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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