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

James River Corp. — Predicate Candidate Screening

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

38 daysmedian FDA review time
80 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K894505COTOLIN DRAIN SPONGE AND DRESSING SPONGEJames River Corp.1989-09-15580
K894147VISULIN TRANSPARENT ADHESIVE DRESSINGJames River Corp.1989-08-09560
K892580CARETOUCH EXAMINATION GLOVESJames River Corp.1989-07-14950
K893939ISOLATION MASKSJames River Corp.1989-07-14440
K894034MODIFIED LABELING OF SURGICAL GLOVESJames River Corp.1989-07-14380
K890459JAMES RIVER BIOGEL POWDERLESS SURGICAL GLOVESJames River Corp.1989-04-20800
K883802CARETEX CENTRAL SUPPLY WRAPJames River Corp.1988-10-21440
K884112CARETEX OR TOWELJames River Corp.1988-10-13140
K883657SKID RESISTANT, LONG LASTING SHOE COVERSJames River Corp.1988-09-15200
K880481CARETEX SURGEON'S CAPSJames River Corp.1988-02-24190
K880431CARETEX SURGEON'S HOODSJames River Corp.1988-02-24230
K880093CARETEX SKID RESISTANT SHOE COVERSJames River Corp.1988-01-29170
K864550CARETEX SHOE COVERSJames River Corp.1986-12-24350
K864479CARETEX ISOLUTION GOWNSJames River Corp.1986-12-09260
K823513CENTRAL SUPPLY ROOM WRAPJames River Corp.1983-01-07390

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