Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Daun International, Inc. · Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

84 daysmedian FDA review time
109 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K852174MERIVAARA OBSTETRIC CHAIR/BED MODEL 358Daun International, Inc.1985-09-061090
K851550MERIVAARA GERIATRIC CHAIRDaun International, Inc.1985-07-09840
K851548AHLBERGS KOMBI I & KOMBI II MOBILE TRANSFER CHAIRSDaun International, Inc.1985-07-09840
K851553MERIUAARA & ERACARE WHEELCHAIRSDaun International, Inc.1985-07-09840
K852173MERIVAARA CRIB TROLLEY-MODEL 381Daun International, Inc.1985-06-17280
K851552MERIVAARA HOSPITAL BEDDaun International, Inc.1985-05-08220
K851551MERIVAARA ELECTRIC HOSPITAL BED & ACCESSORIESDaun International, Inc.1985-05-08220

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