Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medisonic U.S.A., Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
109 daysmedian FDA review time
194 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K924577 | MEDIVAC | Medisonic U.S.A., Inc. | 1993-03-23 | 194 | 0 |
| K923660 | MEDISONIC OXYGEN FLOW CONTROLLER | Medisonic U.S.A., Inc. | 1993-01-27 | 189 | 0 |
| K901114 | MEDISONIC HUMDIFIER/INHALER | Medisonic U.S.A., Inc. | 1990-05-22 | 76 | 0 |
| K896192 | MEDISONIC PNEU-NEB | Medisonic U.S.A., Inc. | 1990-01-03 | 70 | 0 |
| K894961 | MEDISONIC ULTRA-SONIC INHALER | Medisonic U.S.A., Inc. | 1989-11-24 | 109 | 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