Nipro Diabetes Systems, Inc.
Lexington, KY, US
Nipro Diabetes Systems, Inc. appears in FDA device records in Lexington, KY. FDA records list 5 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Nipro Diabetes Systems, Inc. between 2001 and 2007. The busiest year on record is 2002, with 2. The most recent is 2007, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2002 | 2 |
| 2005 | 1 |
| 2007 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K071613 | AMIGO INSULIN PUMP | LZG | Substantially Equivalent | |
| K050312 | AMIGO INSULIN PUMP | LZG | Substantially Equivalent | |
| K014114 | GLUCOPRO SYRINGE, MODEL GPSY-XXXXXXXX | FMF | Substantially Equivalent | |
| K013309 | GLUCOPRO EVO INFUSION PUMP | LZG | Substantially Equivalent | |
| K011120 | GLUCOPRO INFUSION SET, MODEL GPISXXXXXXXX SERIES | FPA | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1335-04 | Amigo Insulin Infusion Pump | A FDA inspection of the firm revealed deficiencies in the company's quality system. Problems exhibited may include motor failure or unintended operation. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain