510(k) · Cleared

Cleared

BioNude Lubricant

K180136510(k) TraditionalCleared Jun 1, 2018135-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

Good Clean Love, Inc. · NUC Lubricant, Personal

Cleared on Jun 1, 2018 as substantially equivalent to K052162 (Sheffield Laboratories, Div. of Faria Limited, LLC, 2006) after a 135-day review. Its family tree reaches back 2 generations to 1996.

Decided: Jun 1, 2018
Review: 135 days
Class: Class II
Product code: NUC
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K955648 (1996). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK955648 K-Y Personal LubricantOrtho Pharmaceutical Corp. · 1996
1 generation backK052162 Sheffield Brand Warming Lubrigel Personal LubricantSheffield Laboratories, Div. of Faria Limited, LLC · 2006
This deviceK180136 BioNude LubricantGood Clean Love, Inc. · 2018

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K955648	K-Y Personal Lubricant	Ortho Pharmaceutical Corp.	1996	—
−1	K052162	Sheffield Brand Warming Lubrigel Personal Lubricant	Sheffield Laboratories, Div. of Faria Limited, LLC	2006	—
0 (this device)	K180136	BioNude Lubricant	Good Clean Love, Inc.	2018	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0

FIG. 1 — Lineage of K180136, 1996–2018Source: 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
*	K052162	Sheffield Brand Warming Lubrigel Personal Lubricant Summary page 4 …roduct Code: NUC (lubricant, personal) (a)(3) Identification of Predicate Device: Sheffield Laboratories Warming LubriGel Personal Lubricant (K052162) The predicate device has not been subject to a design related recall. (a)(4) Device Description: BioNude is a 100% isot…	Sheffield Laboratories, Div. of Faria Limited, LLC	2006	—

Also cleared against K052162: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 22 years and passes through 3 companies; a new generation was cleared every 12.3 years on median.
None of the 3 ancestors has a recall.
1 other device also cites its predicate K052162.

How does its category compare?

All NUC devices

NUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?

BioNude 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 and polyisoprene condoms. It is not compatible with polyurethane 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/K180136 · printed Nov 4, 2026

Cite this page

510(k) Report. “K180136: BioNude Lubricant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180136

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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