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

Copal, Inc. — Predicate Candidate Screening

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

249 daysmedian FDA review time
251 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K832721DIGITAL SPHYGMOMANOMETER UA-231Copal, Inc.1984-04-192510
K832723DIGITAL SPHGMOMANOMETER UA-271Copal, Inc.1984-04-172490
K832722DIGITAL SPHYGMOMANOMETER UA-251Copal, Inc.1984-04-172490
K832724ACTIMETER UB-103Copal, Inc.1983-12-221320
K820300ELECTRONIC DIGITAL SPHYGMOMANOMETERCopal, Inc.1982-03-25490

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