Nipro Diabetes Systems, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Nipro Diabetes Systems, Inc.” (first 2001, latest 2007), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 184 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZG | Pump, Infusion, Insulin | 3 | 3 |
| FMF | Syringe, Piston | 1 | 1 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
Review panels
Most recent Nipro Diabetes Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K071613 | AMIGO INSULIN PUMP | LZG | 2007-12-14 | 184 |
| K050312 | AMIGO INSULIN PUMP | LZG | 2005-05-09 | 90 |
| K014114 | GLUCOPRO SYRINGE, MODEL GPSY-XXXXXXXX | FMF | 2002-06-26 | 194 |
| K013309 | GLUCOPRO EVO INFUSION PUMP | LZG | 2002-06-24 | 263 |
| K011120 | GLUCOPRO INFUSION SET, MODEL GPISXXXXXXXX SERIES | FPA | 2001-05-08 | 26 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2004-05-07.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Nipro Diabetes Systems, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via LZG)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via LZG)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Nipro Medical Corporation (62 510(k)s)
- Nipro Diagnostics, Inc. (4 510(k)s)
- Nipro Renal Solutions USA, Corp. (2 510(k)s)
- Nipro Company, Ltd. (1 510(k)s)
- Nipro Technical Solutions, Incoporated (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Nipro Diabetes Systems, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Nipro Diabetes Systems, Inc.” (first 2001, latest 2007), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Nipro Diabetes Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nipro Diabetes Systems, Inc. is 184 days.
Which FDA product codes appear under Nipro Diabetes Systems, Inc.?
The most frequent FDA product codes under this applicant name are LZG (Pump, Infusion, Insulin, 3); FMF (Syringe, Piston, 1); FPA (Set, Administration, Intravascular, 1).
Next steps
- See all 5 Nipro Diabetes Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LZG, Nipro Diabetes Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.