Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Datex Medical Instrumentation, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
91 daysmedian FDA review time
543 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K955026 | AS/3 NMT MODULE | Datex Medical Instrumentation, Inc. | 1997-04-28 | 543 | 1 |
| K961063 | AS/3 CARDIAC OUTPUT & SVO2 MODULE | Datex Medical Instrumentation, Inc. | 1996-05-31 | 74 | 0 |
| K960490 | AS/3 COMPACT AIRWAY MODULE M-CAIOV | Datex Medical Instrumentation, Inc. | 1996-05-03 | 91 | 0 |
| K953006 | AS/3 NETWORK LINK | Datex Medical Instrumentation, Inc. | 1995-09-27 | 91 | 0 |
| K912530 | CARDIOCAP II(TM) | Datex Medical Instrumentation, Inc. | 1991-09-05 | 90 | 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