Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Bay Shore Medical Equipment Corp. · 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) |
|---|---|---|---|---|---|
| K922814 | TEC1410 ANATOMICAL PROGRAMMING GENERATOR-MODIFICAT | Bay Shore Medical Equipment Corp. | 1992-09-11 | 101 | 0 |
| K904397 | TEC 1410 | Bay Shore Medical Equipment Corp. | 1990-11-13 | 49 | 0 |
| K892342 | TEC 2750 PHOENIX DEDICATED MAMMOGRAPHIC SYSTEM | Bay Shore Medical Equipment Corp. | 1989-11-17 | 226 | 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