Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
American Mcgaw · Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
50 daysmedian FDA review time
119 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K853549 | MCGAW/DROP WATCH FLOW MONITOR | American Mcgaw | 1985-11-12 | 78 | 0 |
| K843639 | ADD-A-VIAL SOLUTION TRANSFER DEVICE | American Mcgaw | 1985-01-14 | 119 | 0 |
| K843954 | MIXING CONTAINER | American Mcgaw | 1984-11-28 | 50 | 0 |
| K841729 | ACCUPRO ENTERAL FEEDING PUMP | American Mcgaw | 1984-06-01 | 37 | 0 |
| K840212 | CONCENTRATED PLATELET ADMIN. SET | American Mcgaw | 1984-03-06 | 47 | 4 |
| K840388 | PAB IV CONTAINER | American Mcgaw | 1984-03-06 | 36 | 0 |
| K831716 | CAPD - CATHETER ADAPTER | American Mcgaw | 1983-06-24 | 28 | 0 |
| K822240 | ETHYLENE OXIDE STERILIZ. PARAMETRIC REL. | American Mcgaw | 1982-12-30 | 156 | 0 |
| K820133 | MCGAW FAT EMULSION SET | American Mcgaw | 1982-04-06 | 78 | 0 |
| K813092 | ACCUPRO I.V. ADMINISTRATION SET | American Mcgaw | 1981-12-31 | 59 | 0 |
| K810683 | CAPD CATHETER ADAPTER | American Mcgaw | 1981-05-08 | 56 | 0 |
| K810757 | I.V. ADMINISTRATION SET | American Mcgaw | 1981-04-08 | 19 | 0 |
| K810600 | CAPD EXCHANGE SET | American Mcgaw | 1981-03-24 | 18 | 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