Atlas FDA

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

Acutek Adhesive Specialties, Inc. — Predicate Candidate Screening

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

287 daysmedian FDA review time
295 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K974891ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197013Acutek Adhesive Specialties, Inc.1998-10-212950
K974890ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 997002Acutek Adhesive Specialties, Inc.1998-10-132870
K974892ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197012Acutek Adhesive Specialties, Inc.1998-10-132870
K962698ACUTEK'S CLEARPASAGEAcutek Adhesive Specialties, Inc.1996-09-09840
K951644ACUTEK'S CLEARPASSAGEAcutek Adhesive Specialties, Inc.1995-07-03840
K943111TRANSPARENT DRESSINGAcutek Adhesive Specialties, Inc.1994-09-12770

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