# K132618: Onetouch Reveal

- Pathway: 510(k) (Traditional)
- Applicant: Lifescan, Inc.
- Decided: Dec 16, 2013 after 117 days
- Product code: MRZ (Accessories, Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K864318 (1987). 41 ancestors in all.
No later device cites it as a predicate yet.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101806: Aidera Diasend System, Aidera AB (2010)

## Indications for use
OneTouch® RevealTM is indicated for use by individuals or health care professionals in the home or health care facilities for transmitting data from home monitoring devices such as glucose meters and insulin pumps to a server database to support diabetes management. The device is indicated for professional use and over-the-counter sales.

Source page: https://510kreport.com/device/K132618
Methodology: https://510kreport.com/methodology