Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dalton Instrument Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
113 daysmedian FDA review time
243 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K131909 | DALTON LIFT CHAIR | Dalton Instrument Corp. | 2014-02-24 | 243 | 0 |
| K101611 | RELAY POWER WHEELCHAIR | Dalton Instrument Corp. | 2010-09-29 | 113 | 0 |
| K101719 | TACAMO MANUAL WHEELCHAIR | Dalton Instrument Corp. | 2010-08-25 | 68 | 0 |
| K904843 | OSCAR(TM) II CAPNOMETER & PULSE OXIMETER | Dalton Instrument Corp. | 1991-04-09 | 166 | 0 |
| K850178 | DALTON FOLDING WHEELCHAIRS | Dalton Instrument Corp. | 1985-04-25 | 98 | 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