Arkray Factory, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Arkray Factory, Inc.” (first 2014, latest 2019), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 176 days. Since 2017 the median was 219 days, against 228 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2014 | 3 | 39 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 2 | 242 |
| 2018 | 0 | — |
| 2019 | 1 | 133 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Arkray Factory, Inc. took a median 219 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 228 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | 3 | 3 |
| CGA | Glucose Oxidase, Glucose | 2 | 2 |
| PDJ | Hemoglobin A1c Test System | 1 | 1 |
Review panels
Most recent Arkray Factory, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K183306 | GLUCOCARD® W onyx Blood Glucose Monitoring System | NBW | 2019-04-10 | 133 |
| K170064 | GLUCOCARD W Blood Glucose Monitoring System | NBW | 2017-08-16 | 219 |
| K162822 | ADAMS A1c HA-8180V, CALIBRATOR 80 | PDJ | 2017-06-29 | 265 |
| K142336 | GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System | CGA | 2014-09-17 | 27 |
| K142035 | GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, RELION MICRO BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2014-09-05 | 39 |
| K124021 | ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEM | CGA | 2014-06-30 | 550 |
Recalls
openFDA lists no recalls under a recalling firm named Arkray Factory, Inc..
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 USA, Inc. (9 510(k)s)
- Arkray USA, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Arkray Factory, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Arkray Factory, Inc.” (first 2014, latest 2019), across 3 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, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Arkray Factory, Inc. is 176 days. Since 2017: 219 days, versus 228 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Arkray Factory, Inc.?
The most frequent FDA product codes under this applicant name are NBW (System, Test, Blood Glucose, Over The Counter, 3); CGA (Glucose Oxidase, Glucose, 2); PDJ (Hemoglobin A1c Test System, 1).
Next steps
- See all 6 Arkray Factory, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NBW, Arkray Factory, 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.