Atlas FDA

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

Adhezion Biomedical, LLC · Predicate Candidate Screening

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

187 daysmedian FDA review time
295 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K223669SecurePortIV Advanced Catheter Securement AdhesiveAdhezion Biomedical, LLC2023-06-121870
K170505SecurePortIV Catheter Securement AdhesiveAdhezion Biomedical, LLC2017-09-292200
K161011SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical SkAdhezion Biomedical, LLC2016-11-082110
K150866SURGISEAL Topical Skin AdhesvieAdhezion Biomedical, LLC2015-07-171070
K133963SURGISEAL TWIST (TM) TOPICAL SKIN ADHESIVEAdhezion Biomedical, LLC2014-09-092590
K141215SURGISEAL TWIST TOPICAL SKIN ADHESIVEAdhezion Biomedical, LLC2014-08-211010
K140517SURGISEAL TOPICAL SKIN ADHESIVE/SURGISEAL STYLUS TOPICAL SKIAdhezion Biomedical, LLC2014-04-28590
K130329SURGISEAL TOPICAL SKIN ADHESIVEAdhezion Biomedical, LLC2013-12-032950
K130474SURGISEAL TOPICAL SKIN ADHESIVEAdhezion Biomedical, LLC2013-05-31950
K123936SURGISEAL TOPICAL SKIN ADHESIVEAdhezion Biomedical, LLC2013-04-241250

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