Asante Solutions, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
- FDA recalls
- 8
At a glance
Market reach
- United States
- FDA recalls
What Asante Solutions, Inc. makes
Asante Solutions, Inc. manufactures the Snap Insulin Pump System, a device for continuous subcutaneous insulin delivery, and the PEARL Diabetes Management System, a software-based platform for monitoring and managing diabetes care.
The company’s products are classified as Class II medical devices under FDA regulations and are authorised via the 510(k) clearance process. The manufacturer is based in the United States.
Catalogue
Snap Insulin Pump System Ref K142619
Regimes: 510(k) Registry: 510(k)Pearl Diabetes Management System Ref K122483
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 8 recalls initiated by Asante Solutions, Inc., initiated on 2013-11-19. By recorded status: 8 terminated. The reasons filed fall into these groups: mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2013
- 19 Nov 2013 Z-0594-2014 Class II Terminated Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.
- 19 Nov 2013 Z-0595-2014 Class II Terminated Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.
- 19 Nov 2013 Z-0596-2014 Class II Terminated Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.
- 19 Nov 2013 Z-0597-2014 Class II Terminated Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.
- 19 Nov 2013 Z-0598-2014 Class II Terminated Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.
- 19 Nov 2013 Z-0599-2014 Class II Terminated Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.
- 19 Nov 2013 Z-0600-2014 Class II Terminated Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.
- 19 Nov 2013 Z-0601-2014 Class II Terminated Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.
Frequently asked questions
How many devices does Asante Solutions, Inc. have in the registry?
The registry currently lists 2 devices for Asante Solutions, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Asante Solutions, Inc.'s devices?
Among its 2 most recently registered devices, Asante Solutions, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Asante Solutions, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Asante Solutions, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Asante Solutions, Inc.?
FDA recall records list 8 recalls initiated by Asante Solutions, Inc., the most recent initiated on 19 Nov 2013. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Asante Solutions, Inc. in the registry?
The most recently registered devices listed for Asante Solutions, Inc. include Snap Insulin Pump System and PEARL DIABETES MANAGEMENT SYSTEM.