510(k) · Cleared

Cleared

Personal Lubricating Gel

K041129510(k) TraditionalCleared Sep 24, 2004147-day reviewClass II21 CFR 884.5300

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

Qualis, Inc. · NUC Lubricant, Personal

Cleared on Sep 24, 2004 as substantially equivalent to K020827 (Personal Products Co., Div. of Mcneil Ppc, Inc., 2002) after a 147-day review. Its family tree reaches back 1 generation to 2002. 17 later devices descend from it.

Decided: Sep 24, 2004
Review: 147 days
Class: Class II
Product code: NUC
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K020827 (2002). 17 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK020827 K-Y Brand Ultra Gel Personal LubricantPersonal Products Co., Div. of Mcneil Ppc, Inc. · 2002
This deviceK041129 Personal Lubricating GelQualis, Inc. · 2004
Descendant · cites it directly · 15 of its ownK051295 I-D GlideWestridge Laboratories, Inc. · 2006
Descendant · 2 generations on · 12 of its ownK150480 JO H20 Water Based Personal LubricantUnited Consortium, Inc. · 2015
Descendant · 3 generations on · 9 of its ownK160211 Wet Original Personal LubricantTrigg Laboratories D/B/A Wet International · 2016
Descendant · 4 generations on · 6 of its ownK183384 JO Agape Original Personal Lubricant, MUSE Essence Water-Based…United Consortium · 2019
Descendant · 5 generations on · 5 of its ownK200208 Agape Warming Personal LubricantCC Wellness, LLC · 2020

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2006high 4 (2021) · low 0 (2007)2026

Most influential descendants

Showing 5 of 17 · See all

K051295I-D GlideWestridge Laboratories, Inc. · 2006 · cites it directly15descendants
K150480JO H20 Water Based Personal LubricantUnited Consortium, Inc. · 2015 · 2 generations on12descendants
K160211Wet Original Personal LubricantTrigg Laboratories D/B/A Wet International · 2016 · 3 generations on9descendants
K183384JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife…United Consortium · 2019 · 4 generations on6descendants
K200208Agape Warming Personal LubricantCC Wellness, LLC · 2020 · 5 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K020827	K-Y Brand Ultra Gel Personal Lubricant	Personal Products Co., Div. of Mcneil Ppc, Inc.	2002	—
0 (this device)	K041129	Personal Lubricating Gel	Qualis, Inc.	2004	—
+1	K051295	I-D Glide	Westridge Laboratories, Inc.	2006	—
+2	K150480	JO H20 Water Based Personal Lubricant	United Consortium, Inc.	2015	—
+3	K160211	Wet Original Personal Lubricant	Trigg Laboratories D/B/A Wet International	2016	—
+4	K183384	JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant…	United Consortium	2019	—
+5	K200208	Agape Warming Personal Lubricant	CC Wellness, LLC	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	2	0
2015	2	0
2016	1	0
2017	1	0
2019	2	0
2020	2	0
2021	4	0
2023	2	0
2025	1	0

FIG. 1 — Lineage of K041129, 2002–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K020827	K-Y Brand Ultra Gel Personal Lubricant Summary page 1 …(k) Summary of Information Respecting Safety and Effectiveness A. Legally Marketed Device. Qualis Claims substantial equivalence to K-Y Ultra Gel Personal Lubricant (K020827), currently in commercial distribution by Personal Products Company Division of McNeil-PPC inc.. Device Description. Personal…	Personal Products Co., Div. of Mcneil Ppc, Inc.	2002	—

Also cleared against K020827: 4 other devices →

What descends from it? (17)

See all 17

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

Number	Device	Applicant	Decided	Descendants
K051295	I-D Glide	Westridge Laboratories, Inc.	2006	15
K051288	Vielle Lubricant	Cst Medical Limited	2006	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?

Its one ancestor has no recall.
Of its descendants, K051295 (Westridge Laboratories, Inc., 2006) has gone furthest, with 15 descendants of its own.
4 other devices also cite its predicate K020827.

How does its category compare?

All NUC devices

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

FDA decisions per year · NUC

11in 2025

2007high 21 (2015) · low 2 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NUC

221in 2025

2007high 271 (2008) · low 112 (2022)2026

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

Recalls per year · NUC

3in 2013

2007high 3 (2013) · low 0 (2007)2026

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

Adverse event reports per year · NUC

13in 2025

2007high 19 (2017) · low 0 (2007)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 Lubricating Gel is designed to enhance the ease and comfort of intimate activity and is compatible with latex condoms

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/K041129 · printed Nov 5, 2026

Cite this page

510(k) Report. “K041129: Personal Lubricating Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041129

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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