Atlas FDA

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

Oricare, Inc. — Predicate Candidate Screening

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

K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K131790A9800 ANESTHESIA WORKSTATIONOricare, Inc.2014-05-093250
K120931CRITICAL CARE VENTILATOROricare, Inc.2013-06-064360
K122875ORICARE L2700Oricare, Inc.2012-12-18900
K113338MEDICAL AIR COMPRESSOROricare, Inc.2012-08-102700

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