# K983216: CVS Personal Lubricant

- Pathway: 510(k) (Abbreviated)
- Applicant: San-Mar Laboratories, Inc.
- Decided: May 17, 1999 after 245 days
- Product code: HIS (Condom)
- 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
No predicates in its family tree.
19 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K935291: Astroglide Personal Lubricant. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K033776: Instead Intimate Lubricant (2004), 17 descendants of its own
- K051295: I-D Glide (2006), 15 descendants of its own
- K150480: JO H20 Water Based Personal Lubricant (2015), 12 descendants of its own
- K160211: Wet Original Personal Lubricant (2016), 9 descendants of its own
- K183384: JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant (2019), 6 descendants of its own

## Indications for use
Personal lubrication and lubrication of a body orifice to facilitate entry of a diagnostic or therapeutic device, as a moisturizer for vaginal dryness, and to enhance condom use and the ease of intimate activity.

Source page: https://510kreport.com/device/K983216
Methodology: https://510kreport.com/methodology