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

Acacia Laboratories, Inc. · Predicate Candidate Screening

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

56 daysmedian FDA review time
204 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K952419STERIGAUZE GEL DRESSINGAcacia Laboratories, Inc.1995-07-26640
K952420STERIGAUZE WET DRESSINGAcacia Laboratories, Inc.1995-07-12500
K951861STERICARE WOUND CARE GELAcacia Laboratories, Inc.1995-07-11810
K952414PREFILLED SYRINGE FOR INFLATION OF FOLEY CATHETERAcacia Laboratories, Inc.1995-06-23310
K951914HYDRACARE ABSORBENT WOUND DRESSINGAcacia Laboratories, Inc.1995-05-15210
K950344HORIZON FOLEY CATHETERIZATION TRAY WITHOUT CATHETERAcacia Laboratories, Inc.1995-03-24560
K913408STERILE PLASTIC DRAPEAcacia Laboratories, Inc.1992-03-122260
K901761STERILE SUCTION TUBING SETAcacia Laboratories, Inc.1990-05-07190
K892856NEWMARK(TM) CORONARY ARTERY BYPASS GRAFT MARKERSAcacia Laboratories, Inc.1989-11-082040
K892804NEWCHILL(TM) CARDIAC INSULATORAcacia Laboratories, Inc.1989-07-14880
K883654STERI-TAG(TM) STERILE LABEL SETSAcacia Laboratories, Inc.1988-10-13480
K884055SURGI-TAG(TM) STERILE LABEL SETSAcacia Laboratories, Inc.1988-10-13170

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