Awareness Technology, Inc.: FDA clearances and approvals
Awareness Technology, Inc. has 18 FDA 510(k) clearances (first 1985, latest 2018), across 10 product codes in 2 review panels. Median 510(k) review time: 65 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 284 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Awareness Technology, Inc.'s cleared 510(k)s took a median 284 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 248 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 8 | 8 |
| LCP | Assay, Glycosylated Hemoglobin | 2 | 2 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 | 1 |
| JFS | Coulometric, Chloride | 1 | 1 |
| JGS | Electrode, Ion Specific, Sodium | 1 | 1 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | 1 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 | 1 |
| JQW | Station, Pipetting And Diluting, For Clinical Use | 1 | 1 |
| KHG | Whole Blood Hemoglobin Determination | 1 | 1 |
Review panels
- Clinical Chemistry (15)
- Hematology (3)
Most recent Awareness Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K171476 | SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) | JGS | 2018-02-27 | 284 |
| K013420 | CHEMWELL, ALSO KNOWN AS PROJECT 2900 | JLW | 2002-07-19 | 277 |
| K010877 | CHEMWELL, MODEL 2900 | CIX | 2001-05-23 | 61 |
| K974762 | STAT TRACKS | JJQ | 1998-01-28 | 40 |
| K943729 | DYE CHECK STRIPS 545-630 | JJY | 1994-12-29 | 149 |
| K941394 | STAT FAX 2600 | JQW | 1994-06-03 | 73 |
| K923598 | REDI-CHECK PHOTMETER Q.A. | JFS | 1992-10-14 | 86 |
| K900224 | STAT FAX(TM)-2100 | JJQ | 1990-03-01 | 43 |
| K892656 | DRI-DYE CHECK STRIPS (TM)-405 | JJX | 1989-05-22 | 39 |
| K882938 | STAT FAX(TM) | JJQ | 1988-09-09 | 58 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Awareness Technology, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Awareness Technology, Inc. have?
Awareness Technology, Inc. has 18 FDA 510(k) clearances (first 1985, latest 2018), across 10 product codes in 2 review panels.
How long does FDA take to clear Awareness Technology, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Awareness Technology, Inc.'s cleared 510(k)s is 65 days.
What devices does Awareness Technology, Inc. make?
Its most frequent FDA product codes are JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use, 8); LCP (Assay, Glycosylated Hemoglobin, 2); CIX (Bromcresol Green Dye-Binding, Albumin, 1).
Has Awareness Technology, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Awareness Technology, Inc. Related entities may recall under other names.
Next steps
- See all 18 Awareness Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JJQ, Awareness Technology, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.