510(k) · Cleared

Cleared

K-Y Lubricating Jelly

K810310510(k) TraditionalCleared Apr 21, 198175-day reviewClass I21 CFR 880.6375

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Johnson & Johnson Professionals, Inc. · KMJ Lubricant, Patient

Cleared on Apr 21, 1981 after a 75-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 128 later devices descend from it.

Decided: Apr 21, 1981
Review: 75 days
Class: Class I
Product code: KMJ
Recalls: None
Predicates: 0

128 later devices descend from it, 6 citing it directly.

This deviceK810310 K-Y Lubricating JellyJohnson & Johnson Professionals, Inc. · 1981
Descendant · cites it directly · 120 of its ownK935299 AstroglideBiofilm, Inc. · 1994
Descendant · 2 generations on · 40 of its ownK072647 Glycerin & Paraben Free AstroglideBiofilm, Inc. · 2008
Descendant · 2 generations on · 40 of its ownK032124 Durex Play LubricantSsl Americas, Inc. · 2004
Descendant · 2 generations on · 27 of its ownK062682 CVS Personal Lubricant and MoisturizerLake Consumer Products, Inc. · 2007
Descendant · 2 generations on · 24 of its ownK061466 IntimolDlc Laboratories, Inc. · 2006

Showing 5 of 128 descendants. See all descendants

Descendants cleared per year

1994high 11 (2026) · low 0 (1995)2026

Most influential descendants

Showing 5 of 128 · See all

K935299AstroglideBiofilm, Inc. · 1994 · cites it directly120descendants
K072647Glycerin & Paraben Free AstroglideBiofilm, Inc. · 2008 · 2 generations on40descendants
K032124Durex Play LubricantSsl Americas, Inc. · 2004 · 2 generations on40descendants
K062682CVS Personal Lubricant and MoisturizerLake Consumer Products, Inc. · 2007 · 2 generations on27descendants
K061466IntimolDlc Laboratories, Inc. · 2006 · 2 generations on24descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K810310	K-Y Lubricating Jelly	Johnson & Johnson Professionals, Inc.	1981	—
+1	K935299	Astroglide	Biofilm, Inc.	1994	—
+2	K072647	Glycerin & Paraben Free Astroglide	Biofilm, Inc.	2008	—
+2	K032124	Durex Play Lubricant	Ssl Americas, Inc.	2004	—
+2	K062682	CVS Personal Lubricant and Moisturizer	Lake Consumer Products, Inc.	2007	—
+2	K061466	Intimol	Dlc Laboratories, Inc.	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1997	1	0
2002	2	0
2003	1	0
2004	1	0
2005	2	0
2006	4	0
2007	2	0
2008	6	0
2009	1	0
2010	3	0
2011	2	0
2012	2	0
2013	5	0
2014	6	0
2015	10	0
2016	6	0
2017	9	0
2018	6	0
2019	6	0
2020	8	0
2021	8	0
2022	10	0
2023	5	0
2024	4	0
2025	6	0
2026	11	0

FIG. 1 — Lineage of K810310, 1981–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KMJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (128)

See all 128

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K935299	Astroglide	Biofilm, Inc.	1994	120
K080978	Walgreen's Personal Lubricating Jelly	Topco Sales	2009	2
K101585	K-Y Brand Long Lasting Vaginal Moisturizer	Johnson & Johnson Consumer & Personal Products Wor	2011	0
K080042	Spirus Medical Surgical Instrument	Spirus Medical, Inc.	2008	0
K070623	Pharmapac Lubricating Jelly	Pharmapac, LLC	2007	0
K013701	Endo-Glide	Sonotech, Inc.	2002	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, K935299 (Biofilm, Inc., 1994) has gone furthest, with 120 descendants of its own.

How does its category compare?

All KMJ devices

KMJ Lubricant, Patient: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KMJ

1in 2015

2007high 3 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KMJ

141in 2012

2007high 141 (2012) · low 86 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KMJ

1in 2016

2007high 12 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KMJ

1in 2025

2007high 7 (2011) · low 0 (2021)2025

MAUDE reports naming product code KMJ, 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	0	—	0	5
2008	3	86	0	3
2009	1	—	0	1
2010	1	—	1	1
2011	1	—	12	7
2012	3	141	0	2
2013	1	—	0	6
2014	1	—	0	2
2015	1	—	0	4
2016	0	—	1	5
2017	0	—	0	1
2018	0	—	0	5
2019	0	—	0	2
2020	0	—	0	1
2021	0	—	0	0
2022	0	—	0	4
2023	0	—	0	4
2024	0	—	0	3
2025	0	—	0	1
2026	0	—	0	—

https://510kreport.com/device/K810310 · printed Nov 5, 2026

Cite this page

510(k) Report. “K810310: K-Y Lubricating Jelly.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K810310

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026