Atlas FDA

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

Canopus Medical Supply Co., Ltd. · Predicate Candidate Screening

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

46 daysmedian FDA review time
401 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K120798DISPOSABLE POWER FREE VINYL EXAM GLOVE, PINK COLORCanopus Medical Supply Co., Ltd.2012-05-14600
K120746DISPOSABLE POWDER FREE VINYL EXAM GLOVESCanopus Medical Supply Co., Ltd.2012-04-27460
K023452OPUS-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WICanopus Medical Supply Co., Ltd.2003-11-204010
K023728DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOECanopus Medical Supply Co., Ltd.2003-01-07620
K022368DISPOSABLE POWDER FREE VINYL EXAM GLOVES, WITH VITAMIN ECanopus Medical Supply Co., Ltd.2002-09-05450
K013753DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COCanopus Medical Supply Co., Ltd.2001-12-10270
K963710PACER PLUS SYNTHETIC MEDICAL VINYL PATIENT EXAMINATION GLOVECanopus Medical Supply Co., Ltd.1996-10-24380
K941357VINYL EXAMINATION GLOVE, POWDER FREECanopus Medical Supply Co., Ltd.1994-04-29390

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