Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Datrix — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
28 daysmedian FDA review time
194 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K053083 | DATRIX CARDIO WIFI ELECTROCARDIOGRAPH | Datrix | 2005-11-30 | 28 | 0 |
| K052883 | CARDIOSERVER | Datrix | 2005-11-01 | 19 | 1 |
| K031074 | DIGITAL AMBULATORY ECG (HOLTER) RECORDER | Datrix | 2003-10-15 | 194 | 0 |
| K982975 | DIGITAL ECG HOLTER RECORDER, MODEL DR512 | Datrix | 1998-11-10 | 76 | 0 |
| K921068 | GIKTER ECG CASSETTE TAPE RECORDER MODEL XR 300 | Datrix | 1992-03-30 | 24 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda