Accumetrics, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Accumetrics, Inc.” (first 1999, latest 2015), across 1 product code in 1 review panel. Median 510(k) review time under this name: 167 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 | 1 | 420 |
| 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 |
|---|---|---|---|
| JOZ | System, Automated Platelet Aggregation | 7 | 7 |
Review panels
- Hematology (7)
Most recent Accumetrics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K141427 | ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST | JOZ | 2015-07-24 | 420 |
| K051231 | VERIFYNOW-P2Y12 ASSAY | JOZ | 2005-08-05 | 84 |
| K042423 | VERIFYNOW-ASPIRIN ASSAY | JOZ | 2004-10-06 | 29 |
| K012701 | ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA) | JOZ | 2002-06-12 | 302 |
| K013596 | MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP) | JOZ | 2002-05-16 | 197 |
| K011337 | ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA) | JOZ | 2001-10-16 | 167 |
| K992531 | ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA SYSTEM RPFA-TRAP LEVEL ONE QC, ULTEGRA SYSTEM | JOZ | 1999-12-20 | 145 |
Recalls
7 product recalls in 6 recall events; 0 initiated in the last five years. Most recent: 2014-02-13.
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 Accumetrics, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Accumetrics, Inc.” (first 1999, latest 2015), across 1 product code 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 Accumetrics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Accumetrics, Inc. is 167 days.
Which FDA product codes appear under Accumetrics, Inc.?
The most frequent FDA product codes under this applicant name are JOZ (System, Automated Platelet Aggregation, 7).
Next steps
- See all 7 Accumetrics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JOZ, Accumetrics, 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.