Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sorba Medical Systems, Inc. · 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) |
|---|---|---|---|---|---|
| K014299 | SORBA STEORRA NON-INVASIVE IMPEDANCE CARDIOGRAPH | Sorba Medical Systems, Inc. | 2002-01-30 | 30 | 0 |
| K950389 | SORBA MODEL CIC-1000 NON-INVASIVE HEMODYNAMIC MONITOR | Sorba Medical Systems, Inc. | 1995-08-15 | 195 | 0 |
| K901926 | SORBA MODEL CIC-1000 W/NEW ELECTRODES | Sorba Medical Systems, Inc. | 1990-06-12 | 43 | 0 |
| K895017 | SORBA MODEL CIC-1000, COMP. IMPEDANCE CARDIOGRAPH | Sorba Medical Systems, Inc. | 1990-03-14 | 218 | 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