Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
North American Biologicals, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
44 daysmedian FDA review time
163 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K820301 | PLASMA POOLER HEAT SEALER | North American Biologicals, Inc. | 1982-04-09 | 64 | 0 |
| K801219 | PLASMAPOOLER | North American Biologicals, Inc. | 1980-10-31 | 163 | 0 |
| K801425 | RH CONTROL | North American Biologicals, Inc. | 1980-07-14 | 27 | 0 |
| K781862 | BLOOD GROUP SUBSTANCE A | North American Biologicals, Inc. | 1978-12-20 | 44 | 0 |
| K781895 | BLOOD GROUP SUBSTANCE B | North American Biologicals, Inc. | 1978-12-20 | 44 | 0 |
| K781896 | BLOOD GROUP SUBSTANCE A,B | North American Biologicals, Inc. | 1978-12-20 | 44 | 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