Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
B&J Manufacturing , Ltd. — 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) |
|---|---|---|---|---|---|
| K201532 | B&J DVT Calf/Thigh Garments, Models 801/830 Series | B&J Manufacturing , Ltd. | 2020-09-19 | 103 | 0 |
| K201547 | B&J DVT Foot Garments, Models 820 Series | B&J Manufacturing , Ltd. | 2020-09-18 | 101 | 0 |
| K200568 | B&J MHP800 Deep Vein Thrombosis (DVT) Prevention System | B&J Manufacturing , Ltd. | 2020-07-10 | 128 | 0 |
| K200154 | B&J DVT Compression Devices MHH800/MHH800SQ | B&J Manufacturing , Ltd. | 2020-07-08 | 168 | 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