Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Central Biological Co. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
21 daysmedian FDA review time
42 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K812330 | DIALYSATE CONCENTRATE | Central Biological Co. | 1981-09-29 | 42 | 0 |
| K792238 | CRPTELL | Central Biological Co. | 1979-11-30 | 23 | 0 |
| K792027 | PREGTELL I | Central Biological Co. | 1979-10-30 | 21 | 0 |
| K790801 | STERILE DEFIBRINATED SHEEP BLOOD | Central Biological Co. | 1979-05-03 | 14 | 0 |
| K790351 | RHEUMATELL | Central Biological Co. | 1979-03-15 | 21 | 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