Arkray Factory USA, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Arkray Factory USA, Inc.” (first 2007, latest 2011), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 185 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 |
|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | 5 | 5 |
| CGA | Glucose Oxidase, Glucose | 4 | 4 |
Review panels
Most recent Arkray Factory USA, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K110709 | ARK CARE DIABETES MANAGMENT SYSTEM | NBW | 2011-05-19 | 66 |
| K093819 | ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER) | NBW | 2010-06-09 | 177 |
| K092104 | ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM | CGA | 2009-11-24 | 133 |
| K091102 | ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS | CGA | 2009-10-23 | 190 |
| K090653 | POCKETCHEM EZ BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2009-10-09 | 212 |
| K090332 | ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001 | NBW | 2009-08-14 | 185 |
| K082417 | GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110 | CGA | 2008-10-21 | 60 |
| K073416 | ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM | CGA | 2008-06-13 | 193 |
| K063771 | GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2007-08-09 | 231 |
Recalls
3 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2019-05-03.
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.
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.
- Arkray, Inc. (18 510(k)s)
- Arkray Factory, Inc. (6 510(k)s)
- Arkray USA, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Arkray Factory USA, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Arkray Factory USA, Inc.” (first 2007, latest 2011), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Arkray Factory USA, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Arkray Factory USA, Inc. is 185 days.
Which FDA product codes appear under Arkray Factory USA, Inc.?
The most frequent FDA product codes under this applicant name are NBW (System, Test, Blood Glucose, Over The Counter, 5); CGA (Glucose Oxidase, Glucose, 4).
Next steps
- See all 9 Arkray Factory USA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NBW, Arkray Factory USA, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.