Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Beech Medical, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
24 daysmedian FDA review time
149 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K933732 | BEECH PROLOK | Beech Medical, Inc. | 1993-12-29 | 149 | 0 |
| K831088 | MINI-VOL I.V. SET | Beech Medical, Inc. | 1983-04-28 | 24 | 0 |
| K831089 | INFUSION PUMP | Beech Medical, Inc. | 1983-04-28 | 24 | 0 |
| K831087 | MINI-VOL EXTENSION SET | Beech Medical, Inc. | 1983-04-28 | 24 | 1 |
| K823373 | BENZING RETROGRADE ADMIN. SET | Beech Medical, Inc. | 1982-12-30 | 48 | 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