Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Diametrics Medical, Ltd. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K983198 | TRENDCARE CALIBRATOR MODEL SCU 7007 | Diametrics Medical, Ltd. | 1999-11-23 | 438 | 0 |
| K980380 | NEUROTREND MULTIPARAMETER SENSOR, C7004S, TO OPERATE WITH PA | Diametrics Medical, Ltd. | 1999-07-14 | 527 | 0 |
| K972314 | PARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7 | Diametrics Medical, Ltd. | 1997-12-19 | 182 | 0 |
| K970906 | PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYST | Diametrics Medical, Ltd. | 1997-09-23 | 195 | 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