510(k) · Cleared
ClearedSheffield Brand Warming Lubrigel Personal Lubricant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sheffield Laboratories, Div. of Faria Limited, LLC · NUC Lubricant, Personal
Cleared on Feb 6, 2006 as substantially equivalent to K955648 (Ortho Pharmaceutical Corp., 1996) and 1 other predicate after a 181-day review. Its family tree reaches back 1 generation to 1996. 2 later devices descend from it.
- Decided
- Feb 6, 2006
- Review
- 181 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K955648 (1996). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK955648 K-Y Personal LubricantOrtho Pharmaceutical Corp. · 1996
- This deviceK052162 Sheffield Brand Warming Lubrigel Personal LubricantSheffield Laboratories, Div. of Faria Limited, LLC · 2006
- Descendant · cites it directly · 0 of its ownK180828 Natureplex Warm Touch Warming JellyNatureplex, LLC · 2018
- Descendant · cites it directly · 0 of its ownK180136 BioNude LubricantGood Clean Love, Inc. · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955648 | K-Y Personal Lubricant | Ortho Pharmaceutical Corp. | 1996 | — |
| 0 (this device) | K052162 | Sheffield Brand Warming Lubrigel Personal Lubricant | Sheffield Laboratories, Div. of Faria Limited, LLC | 2006 | — |
| +1 | K180828 | Natureplex Warm Touch Warming Jelly | Natureplex, LLC | 2018 | — |
| +1 | K180136 | BioNude Lubricant | Good Clean Love, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K955648 | K-Y Personal LubricantSummary page 1…K-Y Brand Jelly Personal Lubricant Ortho-McNeil Pharmaceuticals, Inc. 510 (K' No. 5955648 170 Broad Street, New London, CT 06320 USA · h8E96222-1087 * (860) 442-4451 · FAX (860) 442-0356 · Email: genera… | 1996 |
| * | K040164 | K-Y Brand Warming Jelly Personal LubricantSummary page 2…ge 2 === Current Marketed Device: K-Y Brand Warming Jelly Personal Products Company, Div. of McNeil PPC Inc 510 (K) No. K040164 Information supporting claims of substantial equivalence, as defined under the Federal Food Drug and Cosmetic Act, with respect… | 2004 |
| * | — | K-Y Liquid Personal Lubricant Jelly Named without a submission number |
What descends from it? (2)
2 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?
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 penile and vaginal use only (Compatible with latex condoms)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052162 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052162: Sheffield Brand Warming Lubrigel Personal Lubricant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052162
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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