510(k) · Cleared

Cleared

Replens Long-Lasting Vaginal Moisturizer (35G Tube with Reusable Applicator) Model: 83035

K101098510(k) TraditionalCleared Aug 17, 2010119-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

Lil Drug Store Products, Inc. · NUC Lubricant, Personal

Cleared on Aug 17, 2010 as substantially equivalent to K062682 (Lake Consumer Products, Inc., 2007) after a 119-day review. Its family tree reaches back 3 generations to 1981. 17 later devices descend from it.

Decided: Aug 17, 2010
Review: 119 days
Class: Class II
Product code: NUC
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K810310 (1981). 17 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 3 generations backK810310 K-Y Lubricating JellyJohnson & Johnson Professionals, Inc. · 1981
2 generations backK935299 AstroglideBiofilm, Inc. · 1994
1 generation backK062682 CVS Personal Lubricant and MoisturizerLake Consumer Products, Inc. · 2007
This deviceK101098 Replens Long-Lasting Vaginal Moisturizer (35G Tube with Reusable…Lil Drug Store Products, Inc. · 2010
Descendant · cites it directly · 9 of its ownK150883 HyaloGYN Vaginal Hydrating GelFidia Farmaceutici S.P.A. · 2015
Descendant · 2 generations on · 6 of its ownK211998 Desnuda ReflectGood Clean Love, Inc. · 2021
Descendant · 3 generations on · 1 of its ownK241443 Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil…Hathor Professional Skincare, Ltd. · 2025
Descendant · cites it directly · 1 of its ownK201612 Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5Viramal Limited · 2021
Descendant · cites it directly · 1 of its ownK190752 SatisfaiteFemmepharma Consumer Healthcare, LLC · 2019

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2015high 4 (2021) · low 0 (2017)2026

Most influential descendants

Showing 5 of 17 · See all

K150883HyaloGYN Vaginal Hydrating GelFidia Farmaceutici S.P.A. · 2015 · cites it directly9descendants
K211998Desnuda ReflectGood Clean Love, Inc. · 2021 · 2 generations on6descendants
K241443Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla…Hathor Professional Skincare, Ltd. · 2025 · 3 generations on1descendant
K201612Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5Viramal Limited · 2021 · cites it directly1descendant
K190752SatisfaiteFemmepharma Consumer Healthcare, LLC · 2019 · cites it directly1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K810310	K-Y Lubricating Jelly	Johnson & Johnson Professionals, Inc.	1981	—
−2	K935299	Astroglide	Biofilm, Inc.	1994	—
−1	K062682	CVS Personal Lubricant and Moisturizer	Lake Consumer Products, Inc.	2007	—
0 (this device)	K101098	Replens Long-Lasting Vaginal Moisturizer (35G Tube with Reusable Applicator)…	Lil Drug Store Products, Inc.	2010	—
+1	K150883	HyaloGYN Vaginal Hydrating Gel	Fidia Farmaceutici S.P.A.	2015	—
+2	K211998	Desnuda Reflect	Good Clean Love, Inc.	2021	—
+3	K241443	Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe…	Hathor Professional Skincare, Ltd.	2025	—
+1	K201612	Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5	Viramal Limited	2021	—
+1	K190752	Satisfaite	Femmepharma Consumer Healthcare, LLC	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	0
2016	1	0
2019	1	0
2020	3	0
2021	4	0
2023	1	0
2025	2	0
2026	4	0

FIG. 1 — Lineage of K101098, 1981–2026Source: 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
*	K062682	CVS Personal Lubricant and Moisturizer Summary page 1 …Review Panel: Obstetrics/Gynecology Predicate Devices: Device Name: CVS Personal Lubricant & Moisturizer 510(k) Number: K062682 Product Code: NUC, MMS Intended Use: Replens is a personal lubricant for vaginal application, i…	Lake Consumer Products, Inc.	2007	—

Also cleared against K062682: 3 other devices →

What descends from it? (17)

See all 17

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

Number	Device	Applicant	Decided	Descendants
K150883	HyaloGYN Vaginal Hydrating Gel	Fidia Farmaceutici S.P.A.	2015	9
K201612	Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5	Viramal Limited	2021	1
K190752	Satisfaite	Femmepharma Consumer Healthcare, LLC	2019	1
K152507	Dr. Wolff Vagisan Moisturising Cream	Dr. August Wolff GmbH & Co. KG Arzeimittel	2016	1
K203818	Replens Long-Lasting Vaginal Moisturizer	Church & Dwight Co., Inc.	2021	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?

The line of descent spans 29 years and passes through 4 companies; a new generation was cleared every 12.8 years on median.
None of the 3 ancestors has a recall.
Of its descendants, K150883 (Fidia Farmaceutici S.P.A., 2015) has gone furthest, with 9 descendants of its own.
3 other devices also cite its predicate K062682.

How does its category compare?

All NUC devices

NUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?

Replens is a personal lubricant for 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 condoms and synthetic (polyurethane and polyisoprene) condoms.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K101098 · printed Nov 4, 2026

Cite this page

510(k) Report. “K101098: Replens Long-Lasting Vaginal Moisturizer (35G Tube with Reusable Applicator) Model: 83035.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K101098

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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