# K152628: Pulse H20h!

- Pathway: 510(k) (Traditional)
- Applicant: Toaster Labs, Inc.
- Decided: Jul 11, 2016 after 300 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: 5 generations back to K810310 (1981). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122476: Lifestyles Smooth 2-in-1 Massage & Lubricant, Ansell Healthcare Products, LLC (2013) Summary page 4.

## Most influential descendants
- K202017: Passion Natural Water Based Lubricant (2021), 0 descendants of its own

## Indications for use
The Pulse™ H2Oh! personal lubricant is intended for vaginal and/or penile application to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity, and supplement the body’s natural lubrication. This personal lubricant is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms

Source page: https://510kreport.com/device/K152628
Methodology: https://510kreport.com/methodology