Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dalton Medical Corp. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
81 daysmedian FDA review time
134 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K080373 | TACAHE PC1350 POWER WHEELCHAIR | Dalton Medical Corp. | 2008-04-14 | 62 | 0 |
| K071282 | MODEL SEGAEGO 4D SCOOTER | Dalton Medical Corp. | 2007-07-27 | 81 | 0 |
| K071284 | MODEL SEGAEGO 3D SCOOTER | Dalton Medical Corp. | 2007-07-26 | 80 | 0 |
| K052534 | TACAHE | Dalton Medical Corp. | 2006-01-27 | 134 | 0 |
| K052496 | PRIMECHAIR | Dalton Medical Corp. | 2005-11-04 | 53 | 0 |
| K021199 | PRIMECHAIR | Dalton Medical Corp. | 2002-07-12 | 87 | 0 |
| K010395 | E-POWER | Dalton Medical Corp. | 2001-05-11 | 91 | 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