Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Linde Medical Sensors AG · 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) |
|---|---|---|---|---|---|
| K043357 | TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL | Linde Medical Sensors AG | 2005-03-04 | 88 | 0 |
| K032291 | TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM | Linde Medical Sensors AG | 2004-08-24 | 397 | 0 |
| K003943 | MICROGAS 7650 TRANSCUTANEOUS MONITOR | Linde Medical Sensors AG | 2001-05-04 | 134 | 0 |
| K991644 | MICROGAS 7650 TRANSCUTANEOUS MONITOR | Linde Medical Sensors AG | 1999-05-21 | 8 | 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