510(k) · Cleared

Cleared

K-Y Brand Sensual Mist

K053397510(k) SpecialCleared Feb 17, 200673-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

Mcneil-Ppc, Inc. · NUC Lubricant, Personal

Cleared on Feb 17, 2006 after a 73-day review. The FDA summary names its predicate without a number.

Decided: Feb 17, 2006
Review: 73 days
Class: Class II
Product code: NUC
Recalls: None
Predicates: 0

The FDA summary names its predicate without a number.

FIG. 1 — Lineage of K053397Source: FDA 510(k) database · 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
*	—	K-Y® Brand Liquid Named without a submission number			—

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.

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?

K-Y® Brand SENSUAL MIST™ is intended as a personal lubricant (for penile and vaginal application) compatible with latex condom.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K053397 · printed Nov 4, 2026

Cite this page

510(k) Report. “K053397: K-Y Brand Sensual Mist.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053397

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Page last updated Nov 3, 2026