Arj Medical, Inc.: FDA filings under this applicant name
FDA lists 3 510(k) clearances under the applicant name “Arj Medical, Inc.” (first 2006, latest 2010), plus 1 PMA decision, across 4 product codes in 2 review panels. Median 510(k) review time under this name: 344 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 |
|---|---|---|---|
| CDM | Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | 1 | 1 |
| KQO | Automated Urinalysis System | 1 | 1 |
| LYR | Helicobacter Pylori | 1 | 1 |
| OZA | Test, Urea Adult And Pediatric (Breath), | 1 | 0 |
Review panels
- Clinical Chemistry (2)
- Microbiology (2)
Most recent Arj Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K091472 | URITEST 50 AND URITEST 500 URINE ANALYZER | KQO | 2010-04-27 | 344 |
| K052719 | URITEST 10 URINALYSIS REAGENT STRIPS | CDM | 2006-12-05 | 432 |
| K052708 | PYLO-PLUS | LYR | 2006-05-01 | 214 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P170022 | PMA | PyloPlus UBT System | 2020-02-18 |
Recalls
openFDA lists no recalls under a recalling firm named Arj Medical, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Arj Medical, Inc.?
FDA lists 3 510(k) clearances under the applicant name “Arj Medical, Inc.” (first 2006, latest 2010), plus 1 PMA decision, across 4 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 Arj Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Arj Medical, Inc. is 344 days.
Which FDA product codes appear under Arj Medical, Inc.?
The most frequent FDA product codes under this applicant name are CDM (Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.), 1); KQO (Automated Urinalysis System, 1); LYR (Helicobacter Pylori, 1).
Next steps
- See all 3 Arj Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CDM, Arj Medical, 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.