Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Diagnostic Medical Instruments — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
95 daysmedian FDA review time
252 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K912728 | ALTAIR | Diagnostic Medical Instruments | 1992-02-27 | 252 | 0 |
| K894285 | DMI PC HOLTER SCANNER | Diagnostic Medical Instruments | 1989-09-26 | 95 | 0 |
| K871045 | DMI AMBULATORY HOLTER MONITOR | Diagnostic Medical Instruments | 1987-05-19 | 63 | 0 |
| K830489 | RECORDER DMI | Diagnostic Medical Instruments | 1983-05-25 | 99 | 0 |
| K830407 | ECLIPSE | Diagnostic Medical Instruments | 1983-03-24 | 45 | 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