510(k) · Cleared
ClearedK-Y Brand Warming Jelly Personal Lubricant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Personal Products Company, Div. of Mcneil-Ppc, Inc. · NUC Lubricant, Personal
Cleared on Apr 5, 2004 after a 70-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Apr 5, 2004
- Review
- 70 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK040164 K-Y Brand Warming Jelly Personal LubricantPersonal Products Company, Div. of Mcneil-Ppc, Inc. · 2004
- Descendant · cites it directly · 2 of its ownK052162 Sheffield Brand Warming Lubrigel Personal LubricantSheffield Laboratories, Div. of Faria Limited, LLC · 2006
- Descendant · 2 generations on · 0 of its ownK180828 Natureplex Warm Touch Warming JellyNatureplex, LLC · 2018
- Descendant · 2 generations on · 0 of its ownK180136 BioNude LubricantGood Clean Love, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK123770 Warming Jelly Personal LubricantWisconsin Pharmacal Co., LLC · 2013
- Descendant · cites it directly · 0 of its ownK050212 Personal Warming JellyQualis, Inc. · 2005
Most influential descendants
Showing 5 of 5 · See all- K052162Sheffield Brand Warming Lubrigel Personal LubricantSheffield Laboratories, Div. of Faria Limited, LLC · 2006 · cites it directly2descendants
- K180828Natureplex Warm Touch Warming JellyNatureplex, LLC · 2018 · 2 generations on0descendants
- K180136BioNude LubricantGood Clean Love, Inc. · 2018 · 2 generations on0descendants
- K123770Warming Jelly Personal LubricantWisconsin Pharmacal Co., LLC · 2013 · cites it directly0descendants
- K050212Personal Warming JellyQualis, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040164 | K-Y Brand Warming Jelly Personal Lubricant | Personal Products Company, Div. of Mcneil-Ppc, Inc. | 2004 | — |
| +1 | K052162 | Sheffield Brand Warming Lubrigel Personal Lubricant | Sheffield Laboratories, Div. of Faria Limited, LLC | 2006 | — |
| +2 | K180828 | Natureplex Warm Touch Warming Jelly | Natureplex, LLC | 2018 | — |
| +2 | K180136 | BioNude Lubricant | Good Clean Love, Inc. | 2018 | — |
| +1 | K123770 | Warming Jelly Personal Lubricant | Wisconsin Pharmacal Co., LLC | 2013 | — |
| +1 | K050212 | Personal Warming Jelly | Qualis, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | — | K-Y® Brand Warming LIQUID Personal Lubricant Named without a submission number | |
| * | — | K-Y® Brand JELLY Personal Lubricant Named without a submission number |
What descends from it? (5)
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?
- Of its descendants, K052162 (Sheffield Laboratories, Div. of Faria Limited, LLC, 2006) has gone furthest, with 2 descendants of its own.
How does its category compare?
All NUC devicesNUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Personal Lubricant
For vaginal/penile and condom application during
sexual intimacy
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/K040164 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040164: K-Y Brand Warming Jelly Personal Lubricant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040164
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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