# Lifescan, Inc.

- Location (FDA's records): Milpitas, CA
- FDA decisions: 42 (1981–2013): 42 510(k) clearances
- Product codes: CGA (21), NBW (13), JJX (3), GJS (2), MRZ (1), JJQ (1), LZG (1)
- Predicates its devices cite: 14 (9 its own); citations of its devices by later devices: 61 (9 its own)
- Recalls linked to its devices: 24 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Aidera AB: 1 (https://510kreport.com/company/aidera)
- Welldoc, Inc.: 1 (https://510kreport.com/company/welldoc)
- Becton, Dickinson & CO: 1 (https://510kreport.com/company/becton-dickinson)
- Selfcare, Inc.: 1 (https://510kreport.com/company/selfcare)
- Animas Corp.: 1 (https://510kreport.com/company/animas)

## Firms that cite its devices most
- U. S. Diagnostics, Inc.: 6 (https://510kreport.com/company/u-s-diagnostics)
- American Healthcare Corp.: 6 (https://510kreport.com/company/american-healthcare)
- Infopia Co, Ltd.: 3 (https://510kreport.com/company/infopia)
- Animas Corp.: 3 (https://510kreport.com/company/animas)
- Health Hero Network, Inc.: 2 (https://510kreport.com/company/health-hero-network)
- I-Sens, Inc.: 2 (https://510kreport.com/company/i-sens)
- Hmd Biomedical, Inc.: 2 (https://510kreport.com/company/hmd-biomedical)
- Cilag GmbH International: 2 (https://510kreport.com/company/cilag-international)

## Its most-cited devices
- K024194: One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems (2003), cited by 15
- K984261: Surestep Blood Glucose Monitoring System (1999), cited by 8
- K053529: Onetouch Ultra 2 Blood Glucose Monitoring System (2006), cited by 6
- K984527: IN Touch Diabetes Management Software (1999), cited by 6
- K072543: Onetouch Select Blood Glucose Monitoring System (2007), cited by 3
- K021819: One Touch Ultrasmart Blood Glucose Monitoring System (2002), cited by 3

## Recent decisions
- K132618: Onetouch Reveal (Dec 16, 2013)
- K120558: Onetouch Reveal Diabetes Management Application (Feb 7, 2013)
- K093745: One Touch Verio Blood Glucose Monitoring System (Feb 11, 2011)
- K082590: Symphony Meter Remote (Dec 17, 2008)
- K082513: Onetouch Vita Blood Glucose Monitoring System (Oct 22, 2008)
- K081318: Onetouch Zoom Diabetes Management Program (Jun 9, 2008)
- K073231: Onetouch Ultralink Blood Glucose Monitoring System (Apr 18, 2008)
- K072543: Onetouch Select Blood Glucose Monitoring System (Oct 5, 2007)

Source page: https://510kreport.com/company/lifescan