510(k) · Cleared

Cleared

Lifestyles Smooth 2-in-1 Massage & Lubricant

K122476510(k) TraditionalCleared Mar 7, 2013205-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

Ansell Healthcare Products, LLC · NUC Lubricant, Personal

Cleared on Mar 7, 2013 as substantially equivalent to K060098 (Ssl Americas, Inc., 2006) after a 205-day review. Its family tree reaches back 4 generations to 1981. 13 later devices descend from it.

Decided: Mar 7, 2013
Review: 205 days
Class: Class II
Product code: NUC
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K810310 (1981). 6 ancestors in all. 13 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 4 generations backK810310 K-Y Lubricating JellyJohnson & Johnson Professionals, Inc. · 1981
3 generations backK935299 AstroglideBiofilm, Inc. · 1994
2 generations backK032124 Durex Play LubricantSsl Americas, Inc. · 2004
1 generation backK060098 Durex Play Temptations Assorted LubricantsSsl Americas, Inc. · 2006
This deviceK122476 Lifestyles Smooth 2-in-1 Massage & LubricantAnsell Healthcare Products, LLC · 2013
Descendant · cites it directly · 7 of its ownK140590 Astroglide Sensual StrawberryBiofilm, Inc. · 2014
Descendant · 2 generations on · 3 of its ownK172447 JO Gelato Flavored Personal LubricantsUnited Consortium · 2017
Descendant · cites it directly · 2 of its ownK142790 OneTouch Lubricant GelThai Nippon Rubber Industry Co., Ltd. · 2015
Descendant · cites it directly · 1 of its ownK152628 Pulse H20h!Toaster Labs, Inc. · 2016
Descendant · 2 generations on · 0 of its ownK220226 X-Y Lubricating JellyR&R Medical Corporation, Ltd. · 2023

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2014high 2 (2017) · low 0 (2020)2026

Most influential descendants

Showing 5 of 13 · See all

K140590Astroglide Sensual StrawberryBiofilm, Inc. · 2014 · cites it directly7descendants
K172447JO Gelato Flavored Personal LubricantsUnited Consortium · 2017 · 2 generations on3descendants
K142790OneTouch Lubricant GelThai Nippon Rubber Industry Co., Ltd. · 2015 · cites it directly2descendants
K152628Pulse H20h!Toaster Labs, Inc. · 2016 · cites it directly1descendant
K220226X-Y Lubricating JellyR&R Medical Corporation, Ltd. · 2023 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K810310	K-Y Lubricating Jelly	Johnson & Johnson Professionals, Inc.	1981	—
−3	K935299	Astroglide	Biofilm, Inc.	1994	—
−2	K032124	Durex Play Lubricant	Ssl Americas, Inc.	2004	—
−1	K060098	Durex Play Temptations Assorted Lubricants	Ssl Americas, Inc.	2006	—
0 (this device)	K122476	Lifestyles Smooth 2-in-1 Massage & Lubricant	Ansell Healthcare Products, LLC	2013	—
+1	K140590	Astroglide Sensual Strawberry	Biofilm, Inc.	2014	—
+2	K172447	JO Gelato Flavored Personal Lubricants	United Consortium	2017	—
+1	K142790	OneTouch Lubricant Gel	Thai Nippon Rubber Industry Co., Ltd.	2015	—
+1	K152628	Pulse H20h!	Toaster Labs, Inc.	2016	—
+2	K220226	X-Y Lubricating Jelly	R&R Medical Corporation, Ltd.	2023	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
2005	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0
2015	1	0
2016	1	0
2017	2	0
2018	2	0
2019	2	0
2021	1	0
2022	2	0
2023	1	0

FIG. 1 — Lineage of K122476, 1981–2023Source: 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
*	K060098	Durex Play Temptations Assorted Lubricants Summary page 1 …, vaginal, latex compatible (Class 11, 21 CFR 884.5300, Product Code NUC) Predicate Device: Durex PlayTM Temptations Assorted Lubricants (K(060098) Device Description: LifeStyles® SmoothTM 2-in-I Massage & Lubricant is a non-sterile, water-based personal lubricant designed to…	Ssl Americas, Inc.	2006	—

Also cleared against K060098: 2 other devices →

What descends from it? (13)

See all 13

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

Number	Device	Applicant	Decided	Descendants
K140590	Astroglide Sensual Strawberry	Biofilm, Inc.	2014	7
K142790	OneTouch Lubricant Gel	Thai Nippon Rubber Industry Co., Ltd.	2015	2
K152628	Pulse H20h!	Toaster Labs, Inc.	2016	1

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?

The line of descent spans 32 years and passes through 4 companies; a new generation was cleared every 9.9 years on median.
None of the 6 ancestors has a recall.
Of its descendants, K140590 (Biofilm, Inc., 2014) has gone furthest, with 7 descendants of its own.
2 other devices also cite its predicate K060098.

How does its category compare?

All NUC devices

NUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

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?

LifeStyles® SmoothTM 2-in-I Massage & Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyurethane, and polyisoprene condoms.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K122476 · printed Nov 5, 2026

Cite this page

510(k) Report. “K122476: Lifestyles Smooth 2-in-1 Massage & Lubricant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122476

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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