510(k) · Cleared
ClearedK-Y Personal Lubricant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho Pharmaceutical Corp. · HIS Condom
Cleared on Jun 21, 1996 after a 192-day review. The FDA summary names its predicate without a number. 95 later devices descend from it.
- Decided
- Jun 21, 1996
- Review
- 192 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 0
95 later devices descend from it, 15 citing it directly.
- This deviceK955648 K-Y Personal LubricantOrtho Pharmaceutical Corp. · 1996
- Descendant · cites it directly · 40 of its ownK032124 Durex Play LubricantSsl Americas, Inc. · 2004
- Descendant · cites it directly · 24 of its ownK061466 IntimolDlc Laboratories, Inc. · 2006
- Descendant · cites it directly · 24 of its ownK042563 Durex Play Warmer LubricantSsl Americas, Inc. · 2005
- Descendant · 2 generations on · 23 of its ownK124044 Aloe Cadabra Lubricant, Aloe Cadabra Flavored/Scented LubricantsSeven Oaks Ranch, Inc. · 2013
- Descendant · cites it directly · 22 of its ownK060098 Durex Play Temptations Assorted LubricantsSsl Americas, Inc. · 2006
Showing 5 of 95 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 95 · See all- K032124Durex Play LubricantSsl Americas, Inc. · 2004 · cites it directly40descendants
- K061466IntimolDlc Laboratories, Inc. · 2006 · cites it directly24descendants
- K042563Durex Play Warmer LubricantSsl Americas, Inc. · 2005 · cites it directly24descendants
- K124044Aloe Cadabra Lubricant, Aloe Cadabra Flavored/Scented LubricantsSeven Oaks Ranch, Inc. · 2013 · 2 generations on23descendants
- K060098Durex Play Temptations Assorted LubricantsSsl Americas, Inc. · 2006 · cites it directly22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955648 | K-Y Personal Lubricant | Ortho Pharmaceutical Corp. | 1996 | — |
| +1 | K032124 | Durex Play Lubricant | Ssl Americas, Inc. | 2004 | — |
| +1 | K061466 | Intimol | Dlc Laboratories, Inc. | 2006 | — |
| +1 | K042563 | Durex Play Warmer Lubricant | Ssl Americas, Inc. | 2005 | — |
| +2 | K124044 | Aloe Cadabra Lubricant, Aloe Cadabra Flavored/Scented Lubricants | Seven Oaks Ranch, Inc. | 2013 | — |
| +1 | K060098 | Durex Play Temptations Assorted Lubricants | Ssl Americas, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 6 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 7 | 0 |
| 2016 | 5 | 0 |
| 2017 | 9 | 0 |
| 2018 | 7 | 0 |
| 2019 | 8 | 0 |
| 2020 | 5 | 0 |
| 2021 | 8 | 0 |
| 2022 | 5 | 0 |
| 2023 | 4 | 0 |
| 2025 | 5 | 0 |
| 2026 | 7 | 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 HIS? 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 HIS device
- #1 K262108 FAMA Male Latex Condoms – Aqueous Lubricant…score 13.2 · 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® Jelly Personal Lubricant Named without a submission number | |
| * | — | ASTROGLIDE® Personal Lubricant Named without a submission number |
What descends from it? (95)
See all 9515 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032124 | Durex Play Lubricant | 2004 | 40 |
| K061466 | Intimol | 2006 | 24 |
| K042563 | Durex Play Warmer Lubricant | 2005 | 24 |
| K060098 | Durex Play Temptations Assorted Lubricants | 2006 | 22 |
| K982673 | Just Between US, Personal Lubricant & Condom | 1998 | 18 |
| K033076 | Lifestyles Liquid Personal Lubricant | 2003 | 17 |
| K070587 | Elegance Woman's Lubricant | 2008 | 11 |
| K151884 | K-Y Marilyn Pleasure Gel | 2016 | 3 |
| K051688 | For Play, Slip, Prepair - Personal Lubricants | 2006 | 3 |
| K110325 | Aqua Lube | 2011 | 2 |
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, K032124 (Ssl Americas, Inc., 2004) has gone furthest, with 40 descendants of its own.
How does its category compare?
All HIS devicesHIS Condom: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HIS
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HIS
99in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HIS
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HIS
20in 2025
MAUDE reports naming product code HIS, 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 | 7 | 128 | 1 | 10 |
| 2008 | 3 | 157 | 0 | 11 |
| 2009 | 5 | 241 | 0 | 12 |
| 2010 | 1 | — | 0 | 22 |
| 2011 | 3 | 54 | 0 | 15 |
| 2012 | 7 | 106 | 1 | 10 |
| 2013 | 4 | 208 | 1 | 19 |
| 2014 | 7 | 242 | 0 | 16 |
| 2015 | 3 | 136 | 0 | 8 |
| 2016 | 5 | 115 | 0 | 5 |
| 2017 | 4 | 102 | 0 | 8 |
| 2018 | 2 | — | 0 | 11 |
| 2019 | 1 | — | 0 | 15 |
| 2020 | 4 | 240 | 0 | 12 |
| 2021 | 5 | 233 | 0 | 16 |
| 2022 | 10 | 112 | 0 | 18 |
| 2023 | 2 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 5 | 99 | 0 | 20 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
This device is indicated to enhance the comfort and ease of intimate activity with or without a latex condom. K-Y ® Liquid Personal Lubricant can be safely applied directly to a genital body orifice or a latex condom. The product can be used inside condom:s to facilitate application or outside for lubrication during intercourse.
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/K955648 · printed Nov 5, 2026
Cite this page
510(k) Report. “K955648: K-Y 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/K955648
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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