Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Baurs Krey Assoc., 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) |
|---|---|---|---|---|---|
| K841252 | GLATTELAST COMPRESSION PANTY HOSE | Baurs Krey Assoc., Inc. | 1984-06-27 | 93 | 0 |
| K841215 | GLATTELAST COMPRESSION STOCKINGS | Baurs Krey Assoc., Inc. | 1984-06-07 | 77 | 0 |
| K841171 | TRILICON BREASE PROSTHESIS DIFFERENT | Baurs Krey Assoc., Inc. | 1984-04-25 | 37 | 0 |
| K841253 | COMPRESSION STOCKINGS W/WAIST SUSPENS- | Baurs Krey Assoc., Inc. | 1984-03-26 | 0 | 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