510(k) · Cleared
ClearedK-Y Brand Ultra Gel Personal Lubricant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Personal Products Co., Div. of Mcneil Ppc, Inc. · NUC Lubricant, Personal
Cleared on Jun 12, 2002 after a 90-day review. The FDA summary names its predicate without a number. 31 later devices descend from it.
- Decided
- Jun 12, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 0
31 later devices descend from it, 5 citing it directly.
- This deviceK020827 K-Y Brand Ultra Gel Personal LubricantPersonal Products Co., Div. of Mcneil Ppc, Inc. · 2002
- Descendant · cites it directly · 17 of its ownK041129 Personal Lubricating GelQualis, Inc. · 2004
- Descendant · 2 generations on · 15 of its ownK051295 I-D GlideWestridge Laboratories, Inc. · 2006
- Descendant · 3 generations on · 12 of its ownK150480 JO H20 Water Based Personal LubricantUnited Consortium, Inc. · 2015
- Descendant · 4 generations on · 9 of its ownK160211 Wet Original Personal LubricantTrigg Laboratories D/B/A Wet International · 2016
- Descendant · cites it directly · 9 of its ownK051436 Pre' Vaginal LubricantIngfertlity, LLC · 2006 · Recalled
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K041129Personal Lubricating GelQualis, Inc. · 2004 · cites it directly17descendants
- K051295I-D GlideWestridge Laboratories, Inc. · 2006 · 2 generations on15descendants
- K150480JO H20 Water Based Personal LubricantUnited Consortium, Inc. · 2015 · 3 generations on12descendants
- K160211Wet Original Personal LubricantTrigg Laboratories D/B/A Wet International · 2016 · 4 generations on9descendants
- K051436Pre' Vaginal LubricantIngfertlity, LLC · 2006 · cites it directly9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K020827 | K-Y Brand Ultra Gel Personal Lubricant | Personal Products Co., Div. of Mcneil Ppc, Inc. | 2002 | — |
| +1 | K041129 | Personal Lubricating Gel | Qualis, Inc. | 2004 | — |
| +2 | K051295 | I-D Glide | Westridge Laboratories, Inc. | 2006 | — |
| +3 | K150480 | JO H20 Water Based Personal Lubricant | United Consortium, Inc. | 2015 | — |
| +4 | K160211 | Wet Original Personal Lubricant | Trigg Laboratories D/B/A Wet International | 2016 | — |
| +1 | K051436 | Pre' Vaginal Lubricant | Ingfertlity, LLC | 2006 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | — | K-Y® Brand LIQUID Personal Lubricant Named without a submission number |
What descends from it? (31)
See all 315 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041129 | Personal Lubricating Gel | 2004 | 17 |
| K051436 | Pre' Vaginal Lubricant | 2006 | 9 |
| K143529 | UltraSmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal Moisturizer | 2015 | 0 |
| K060145 | FDS Intimate and Intimate Warming Lubricant | 2006 | 0 |
| K042915 | O'my Natural Lubricant, O'my Natural Flavored Lubricant | 2005 | 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?
- Of its descendants, K041129 (Qualis, Inc., 2004) has gone furthest, with 17 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 compatible with latex condoms, helps enhance 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/K020827 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020827: K-Y Brand Ultra Gel Personal Lubricant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020827
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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