# K042915: O'my Natural Lubricant, O'my Natural Flavored Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: O'My Products Incorporated
- Decided: Aug 31, 2005 after 314 days
- Product code: NUC (Lubricant, Personal)
- Device class: 2
- Regulation: 21 CFR 884.5300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K020827 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020827: K-Y Brand Ultra Gel Personal Lubricant, Personal Products Co., Div. of Mcneil Ppc, Inc. (2002) Summary page 1.
- K021492: K-Y Brand Warming Liquid Personal Lubricant, Personal Products Co., Div. of Mcneil Ppc, Inc. (2002) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K042915
Methodology: https://510kreport.com/methodology