Datrix: FDA clearances and approvals
Datrix has 5 FDA 510(k) clearances (first 1992, latest 2005), across 4 product codes in 1 review panel. Median 510(k) review time: 28 days.
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 |
|---|---|---|---|
| MWJ | Electrocardiograph, Ambulatory (Without Analysis) | 2 | 2 |
| DPS | Electrocardiograph | 1 | 1 |
| DQK | Computer, Diagnostic, Programmable | 1 | 1 |
| DSH | Recorder, Magnetic Tape, Medical | 1 | 1 |
Review panels
- Cardiovascular (5)
Most recent Datrix 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K053083 | DATRIX CARDIO WIFI ELECTROCARDIOGRAPH | DPS | 2005-11-30 | 28 |
| K052883 | CARDIOSERVER | DQK | 2005-11-01 | 19 |
| K031074 | DIGITAL AMBULATORY ECG (HOLTER) RECORDER | MWJ | 2003-10-15 | 194 |
| K982975 | DIGITAL ECG HOLTER RECORDER, MODEL DR512 | MWJ | 1998-11-10 | 76 |
| K921068 | GIKTER ECG CASSETTE TAPE RECORDER MODEL XR 300 | DSH | 1992-03-30 | 24 |
Recalls
openFDA lists no recalls under a recalling firm named Datrix.
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 Datrix have?
Datrix has 5 FDA 510(k) clearances (first 1992, latest 2005), across 4 product codes in 1 review panel.
How long does FDA take to clear Datrix's 510(k)s?
The median time from FDA receipt to decision across Datrix's cleared 510(k)s is 28 days.
What devices does Datrix make?
Its most frequent FDA product codes are MWJ (Electrocardiograph, Ambulatory (Without Analysis), 2); DPS (Electrocardiograph, 1); DQK (Computer, Diagnostic, Programmable, 1).
Has Datrix had device recalls?
openFDA lists no recalls under a recalling firm name matching Datrix. Related entities may recall under other names.
Next steps
- See all 5 Datrix clearances with predicates and recalls
- Run predicate analysis for product code MWJ, Datrix'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.