Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Baxa Corp., Sub. of Cook Group, Inc. · Predicate Candidate Screening
16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
60 daysmedian FDA review time
112 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K910257 | BAXA PCA INFUSOR | Baxa Corp., Sub. of Cook Group, Inc. | 1991-11-07 | 289 | 0 |
| K903159 | VALVE CONTROLLER FOR MICROMACRO COMPOUNDER | Baxa Corp., Sub. of Cook Group, Inc. | 1990-11-07 | 112 | 0 |
| K904225 | KWIKMIX | Baxa Corp., Sub. of Cook Group, Inc. | 1990-11-05 | 53 | 0 |
| K900585 | TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP | Baxa Corp., Sub. of Cook Group, Inc. | 1990-04-18 | 70 | 36 |
| K873875 | BAXA EXACTA-MED PHARMACY PUMP | Baxa Corp., Sub. of Cook Group, Inc. | 1987-11-24 | 63 | 0 |
| K872743 | BAXA TUBING SETS (FOR PHARMACY PUMP) | Baxa Corp., Sub. of Cook Group, Inc. | 1987-10-09 | 88 | 0 |
| K844904 | CYTOSAFE NEEDLE | Baxa Corp., Sub. of Cook Group, Inc. | 1985-02-22 | 67 | 0 |
| K832312 | I.V. TRANSFER NEEDLE | Baxa Corp., Sub. of Cook Group, Inc. | 1983-09-12 | 60 | 0 |
| K832332 | VENTED I.V. TRANSFER NEEDLE | Baxa Corp., Sub. of Cook Group, Inc. | 1983-09-12 | 56 | 0 |
| K832347 | TWOFER NEEDLE | Baxa Corp., Sub. of Cook Group, Inc. | 1983-09-12 | 56 | 0 |
| K832247 | I.V. BAG ADDISEAL | Baxa Corp., Sub. of Cook Group, Inc. | 1983-07-26 | 15 | 0 |
| K832254 | BAXA ADDISEAL | Baxa Corp., Sub. of Cook Group, Inc. | 1983-07-26 | 15 | 0 |
| K820435 | BAXA ADDISEAL | Baxa Corp., Sub. of Cook Group, Inc. | 1982-03-08 | 19 | 0 |
| K813435 | BAXA ADLI SEAL | Baxa Corp., Sub. of Cook Group, Inc. | 1981-12-18 | 10 | 0 |
| K802966 | I.V. ADDITIVE CAP | Baxa Corp., Sub. of Cook Group, Inc. | 1981-01-07 | 47 | 0 |
| K781364 | PINT BOTTLE WELL | Baxa Corp., Sub. of Cook Group, Inc. | 1978-10-17 | 71 | 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