Nipro Diabetes Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Nipro Diabetes Systems, Inc. makes
Nipro Diabetes Systems, Inc. manufactures insulin delivery devices, including pre-filled insulin syringes (GLUCOPRO SYRINGE), disposable infusion sets (GLUCOPRO INFUSION SET and GLUCOPRO EVO INFUSION SET SERIES), and insulin pumps (AMIGO INSULIN PUMP and GLUCOPRO EVO INFUSION PUMP). These products are designed for subcutaneous insulin administration in diabetes management.
The company’s devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The portfolio is listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Glucopro Syringe, Model Gpsy-Xxxxxxxx Ref K014114
Regimes: 510(k) Registry: 510(k)Glucopro Infusion Set, Model Gpisxxxxxxxx Series Ref K011120
Regimes: 510(k) Registry: 510(k)Amigo Insulin Pump Ref K071613
Regimes: 510(k) Registry: 510(k)Glucopro Evo Infusion Pump Ref K013309
Regimes: 510(k) Registry: 510(k)Amigo Insulin Pump Ref K050312
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Nipro Diabetes Systems, Inc., initiated on 2004-05-07. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2004
- 7 May 2004 Z-1335-04 Unclassified (pre-2012) Terminated A FDA inspection of the firm revealed deficiencies in the company's quality system. Problems exhibited may include motor failure or unintended operation.
Frequently asked questions
How many devices does Nipro Diabetes Systems, Inc. have in the registry?
The registry currently lists 5 devices for Nipro Diabetes Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Nipro Diabetes Systems, Inc.'s devices?
Among its 5 most recently registered devices, Nipro Diabetes Systems, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Nipro Diabetes Systems, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Nipro Diabetes Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Nipro Diabetes Systems, Inc.?
FDA recall records list 1 recall initiated by Nipro Diabetes Systems, Inc., the most recent initiated on 7 May 2004. 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 Nipro Diabetes Systems, Inc. in the registry?
The most recently registered devices listed for Nipro Diabetes Systems, Inc. include GLUCOPRO SYRINGE, MODEL GPSY-XXXXXXXX, GLUCOPRO INFUSION SET, MODEL GPISXXXXXXXX SERIES, AMIGO INSULIN PUMP and GLUCOPRO EVO INFUSION PUMP.