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

Carrington Laboratories, Inc. · Predicate Candidate Screening

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

85 daysmedian FDA review time
133 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K022670CARRAKLENZ AND ULTRAKLENZCarrington Laboratories, Inc.2002-10-17660
K012126THE SALICEPT ORAL PATCHCarrington Laboratories, Inc.2001-10-03890
K983182ALOE THERAPY ORAL RINSECarrington Laboratories, Inc.1998-12-10900
K964852RADIACARE ORAL WOUND RINSECarrington Laboratories, Inc.1997-03-03900
K962218CARRASYN HYDROGEL WOUND DRESSING,CARRAGAUZE PADS,CARRAGAUZE Carrington Laboratories, Inc.1996-09-12940
K961758CARASYN HYDROGEL WOUND PRODUCTSCarrington Laboratories, Inc.1996-07-11690
K960428CARRASYN HYDROGEL WOUND DRESSING/FDG PADS/CARAGAUZE STRIPS/PCarrington Laboratories, Inc.1996-03-21690
K953423CASRRASYN ORAL WOUND DRESSINGCarrington Laboratories, Inc.1995-10-111130
K951417CARRASYN HYDROGEL WOUND DRESSING, FDG PADS, CARRAGAUZE PADS,Carrington Laboratories, Inc.1995-05-10430
K944427CARRASYN FDGCarrington Laboratories, Inc.1994-11-29780
K933741CARRASYN ORAL WOUND DRESSINGCarrington Laboratories, Inc.1994-05-042740
K915001CARRINGTON WOUND DRESSING 4X4(TM)Carrington Laboratories, Inc.1992-01-31850
K915002STERILE GAUZE PK STRIPS SAT W/CARR GEL WOUND DRESSCarrington Laboratories, Inc.1992-01-31850
K902345CARRINGTON WOUND DRESSINGCarrington Laboratories, Inc.1990-06-07130
K894541CARRINGTON DERMAL WOUND GELCarrington Laboratories, Inc.1989-11-301330

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