Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Northwest Orthodontics, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
18 daysmedian FDA review time
43 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K800748 | SNAP-WAY HEADGEAR | Northwest Orthodontics, Inc. | 1980-04-10 | 6 | 0 |
| K790843 | SNAP-WAY | Northwest Orthodontics, Inc. | 1979-05-31 | 29 | 0 |
| K780814 | SAFETY STOP NECKSTRAP | Northwest Orthodontics, Inc. | 1978-06-30 | 43 | 0 |
| K780747 | SNAP-WAY | Northwest Orthodontics, Inc. | 1978-05-26 | 18 | 0 |
| K771706 | SAIF-BOW | Northwest Orthodontics, Inc. | 1977-09-20 | 11 | 0 |
| K771095 | J HOOK HEADGEAR | Northwest Orthodontics, Inc. | 1977-06-24 | 4 | 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