Arkray, Inc.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Arkray, Inc.” (first 2002, latest 2024), across 14 product codes in 3 review panels. Median 510(k) review time under this name: 151 days. Since 2017 the median was 527 days, against 174 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 261 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 269 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 2 | 482 |
| 2023 | 1 | 1211 |
| 2024 | 1 | 266 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Arkray, Inc. took a median 527 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 174 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | 3 | 3 |
| CIC | Cresolphthalein Complexone, Calcium | 2 | 2 |
| KQO | Automated Urinalysis System | 2 | 2 |
| CFH | Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase | 1 | 1 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | 1 |
| CIG | Diazo Colorimetry, Bilirubin | 1 | 1 |
| JJF | Analyzer, Chemistry, Micro, For Clinical Use | 1 | 1 |
Plus 4 more product codes.
Review panels
Most recent Arkray, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232416 | AUTION EYE AI-4510 Urine Particle Analysis System | LKM | 2024-05-03 | 266 |
| K193514 | AUTION MAX AX-4060 Urinalysis System | JIL | 2023-04-13 | 1211 |
| K221175 | Multi-Lancet Device 2, ReliOn Premier Lancing Device | QRL | 2022-10-17 | 175 |
| K200788 | Assure Titanium Blood Glucose Monitoring System | PZI | 2022-05-23 | 788 |
| K160062 | AUTION ELEVEN Semi-Automated Urinalysis System | JIL | 2016-10-07 | 269 |
| K121456 | AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL | KQO | 2013-02-01 | 261 |
| K093098 | AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM | KQO | 2009-12-23 | 83 |
| K053401 | SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS | CIC | 2006-03-24 | 108 |
| K051648 | SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS | CGS | 2006-01-31 | 224 |
| K051432 | SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS | CIG | 2005-06-17 | 16 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Arkray, 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 Factory USA, Inc. (9 510(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, Inc.?
FDA lists 18 510(k) clearances under the applicant name “Arkray, Inc.” (first 2002, latest 2024), across 14 product codes in 3 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 Arkray, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Arkray, Inc. is 151 days. Since 2017: 527 days, versus 174 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Arkray, Inc.?
The most frequent FDA product codes under this applicant name are JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative), 3); CIC (Cresolphthalein Complexone, Calcium, 2); KQO (Automated Urinalysis System, 2).
Next steps
- See all 18 Arkray, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JIL, Arkray, 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.