510(k) · Cleared

Cleared

O'my Natural Lubricant, O'my Natural Flavored Lubricant

K042915510(k) TraditionalCleared Aug 31, 2005314-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

O'My Products Incorporated · NUC Lubricant, Personal

Cleared on Aug 31, 2005 as substantially equivalent to K020827 (Personal Products Co., Div. of Mcneil Ppc, Inc., 2002) and 1 other predicate after a 314-day review. Its family tree reaches back 1 generation to 2002.

Decided: Aug 31, 2005
Review: 314 days
Class: Class II
Product code: NUC
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K020827 (2002). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK020827 K-Y Brand Ultra Gel Personal LubricantPersonal Products Co., Div. of Mcneil Ppc, Inc. · 2002
This deviceK042915 O'my Natural Lubricant, O'my Natural Flavored LubricantO'My Products Incorporated · 2005

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)	K042915	O'my Natural Lubricant, O'my Natural Flavored Lubricant	O'My Products Incorporated	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0

FIG. 1 — Lineage of K042915, 2002–2005Source: 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? (2)

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 …Class: I Regulation Number: 21 CFR 880.6375 Regulation Name: Patient Lubricant K020827 - K-Y Brand Ultra Gel K02 1492 - K-Y Brand Warming Liquid Personal Lubricant Cl…	Personal Products Co., Div. of Mcneil Ppc, Inc.	2002	—
*	K021492	K-Y Brand Warming Liquid Personal Lubricant Summary page 1 …ulation Number: 21 CFR 880.6375 Regulation Name: Patient Lubricant K020827 - K-Y Brand Ultra Gel K02 1492 - K-Y Brand Warming Liquid Personal Lubricant Class: 1I Regulation Number: Cond…	Personal Products Co., Div. of Mcneil Ppc, Inc.	2002	—

Also cleared against K020827: 4 other devices →

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?

None of the 2 ancestors has a recall.
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?

Patient Lubricants are devices intended to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device. When used as an accessory to a condom, patient lubricants are deemed Class II Medical Devices.

O'My Lubricant and O'My Flavored Lubricants are principally intended as personal lubricants to supplement the body's own natural lubrication fluids. O'My Lubricants also reduce friction during sexual intercourse enhancing the comfort and ease of intimate sensual activity with or without a latex condom.

O'My Lubricant and O'My Flavored Lubricants are also recommended for personal lubrication when dryness causes discomfort.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042915 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042915: O'my Natural Lubricant, O'my Natural Flavored Lubricant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042915

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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