# Philosys, Inc.

- Location (FDA's records): New York, NY
- FDA decisions: 5 (2013–2015): 5 510(k) clearances
- Names in FDA's records: Philosys, Inc. (4); Philosys Co., Ltd. (1)
- Product codes: NBW (4), CGA (1)
- Predicates its devices cite: 5 (1 its own); citations of its devices by later devices: 2 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- I-Sens, Inc.: 2 (https://510kreport.com/company/i-sens)
- Selfcare, Inc.: 1 (https://510kreport.com/company/selfcare)
- Agamatrix, Inc.: 1 (https://510kreport.com/company/agamatrix)

## Firms that cite its devices most
- Labstyle Innovations, Ltd.: 1 (https://510kreport.com/company/labstyle-innovations)

## Its most-cited devices
- K131230: Gmate Smart Blood Glucose Monitoring System, Gmate Smart Application (2014), cited by 2

## Recent decisions
- K151658: Gmate Origin Blood Glucose Monitoring System (Dec 1, 2015)
- K150299: Gmate SMART Blood Glucose Monitoring System (Nov 19, 2015)
- K141656: Gmate Mini Blood Glucose Monitoring System, Gmate Step Blood Glucose Monitoring System (Oct 2, 2015)
- K131230: Gmate Smart Blood Glucose Monitoring System, Gmate Smart Application (Aug 4, 2014)
- K113636: Blood Glucose Monitoring System (Glucose Oxidase) (Mar 8, 2013)

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