Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Narco Mckesson Co. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
19 daysmedian FDA review time
39 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K801101 | ANALOR FOUR-ORAL SURGERY MODEL | Narco Mckesson Co. | 1980-06-17 | 39 | 0 |
| K801102 | COMPALOR-ORAL SURGERY MODEL | Narco Mckesson Co. | 1980-06-17 | 39 | 0 |
| K801100 | ANALOR FOUR-DENTAL MODEL | Narco Mckesson Co. | 1980-05-28 | 19 | 0 |
| K801103 | COMPALOR-DENTAL MODEL | Narco Mckesson Co. | 1980-05-28 | 19 | 0 |
| K790456 | SERIES 7000 | Narco Mckesson Co. | 1979-03-23 | 17 | 0 |
| K781492 | SERIES 7000 GAS MACHINE | Narco Mckesson Co. | 1978-09-11 | 14 | 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