Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Seismed Instruments, Inc. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K910994 | MODIFIED SEISMOCARDIOGRAPH | Seismed Instruments, Inc. | 1992-01-15 | 318 | 0 |
| K900130 | MODIFIED SEISMOCARDIOGRAPH | Seismed Instruments, Inc. | 1990-03-28 | 82 | 0 |
| K892323 | SEISMOCARDIOGRAPH - SCG(TM) 1000 SERIES | Seismed Instruments, Inc. | 1989-10-30 | 207 | 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