Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
BXH — Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K942645 | B&F MEDICAL OXYGEN REG MECICAL OXY COMPRESS GAS REG | B & F Medical Products, Inc. | 1994-07-27 | 54 | 0 |
| K853040 | PRESSURE GAUGE | Erie Medical | 1985-10-10 | 83 | 0 |
| K843212 | LOW PRESSURE ALARM FOR OXYGEN CYLINDER | Hospitak, Inc. | 1984-09-19 | 35 | 0 |
| K770614 | MONITOR, GAS MANIFOLD | Dynatech Cryomedical Co. | 1977-04-07 | 7 | 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