Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Datascope Corp., Patient Monitoring Division · 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) |
|---|---|---|---|---|---|
| K123211 | A5 ANESTHESIA DELIVERY SYSTEM | Datascope Corp., Patient Monitoring Division | 2013-02-14 | 125 | 0 |
| K091834 | PASSPORT V MONITOR, MODEL 0998-00-6100 | Datascope Corp., Patient Monitoring Division | 2009-07-15 | 23 | 2 |
| K091068 | ACCUTORR V MONITOR, MODEL 0998-00-2000 | Datascope Corp., Patient Monitoring Division | 2009-05-08 | 24 | 1 |
| K080175 | NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01 | Datascope Corp., Patient Monitoring Division | 2008-06-09 | 137 | 2 |
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