510(k) Report

Devices descending from K895920

32 later devices reach Vitapatch Pin Protection Device for Percutaneous through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K003229Biopatch Antimicrobial DressingIntegra Lifesciences Corp.200131—
+2K200641HaloGUARD Protective Disc with CHGAttwill Medical Solutions20200—
+2K1534103M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing3M Company201711
+2K120930CHG Antibacterial Foam Dressing, CHG Antibacterial Patch, CHG Antibacterial Foam Patch…Medtrade Products, Ltd.20120—
+2K121819Surgiclear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and SilverCovalontechnologies, Inc.20123—
+2K103106Chlorashield TM Antimicrobial DressingCare Fusion 213, LLC20110—
+2K093729Guardiva Antimicrobial Haemostatic IV Dressing, 1 in/ 4MM, Sterile, Guard Iva…Hemcon Medical Technologies Europe, Ltd.20101—
+2K080779Irrisept Wound Cleansing SystemIrrimax Corporation200992
+2K0634583M Tegaderm CHG Dressing3M Company2007161
+3K202222Irrisept Wound Debridement and Cleansing SystemIrrimax Corporation20207—
+3K202071SURGIPHOR Wound Irrigation SystemOrthophor, LLC20204—
+3K1719083M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing3M Company201701
+3K163529ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG…Avery Dennison Corporation20171—
+3K140389Chloraderm Antimicrobial Transparent Thin Film Dressing, 2 3/8 X 2 3/4, 4 X 4 3/4Entrotech Life Sciences, Inc.20140—
+3K1236793M Tegaderm CHG Chlorhexidine Gluconate I.V. Port Dressing3M Company201311
+3K113836Benehold CHG Transparent Film Dressing (10X12CM) (8.5X12CM) (6.5X7 CM)Avery Dennison Belgie Bvba20124—
+3K121485Guardiva Antimicrobial Haemstatic IV DressingHemcon Medical Technologies Europe, Ltd.20120—
+3K080620Modification to 3M Tegaderm CHG Dressing3M Company-3M Health Care200871
+4K251866Tegaderm Post-Op Transparent Antimicrobial DressingSolventum US, LLC20250—
+4K213616BD Surgiphor Antimicrobial Irrigation SystemBecton, Dickinson and Company20223—
+4K210536Irrisept Antimicrobial Wound LavageIrrimax Corporation20216—
+4K2008353M Tegaderm CHG Chlorhexidine Gluconate Gel Pad3M Company202001
+4K1707543M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced…3M Company, 3M Healthcare20170—
+4K170407BD ChloraShield IV Dressing with CHG AntimicrobialAvery Dennison Belgie Bvba20170—
+4K152923BD ChloraShield IV Dressing with CHG AntimicrobialAvery Dennison Belgie Bvba20150—
+4K133764Chlorashield IV Dressing with CHG AntimicrobialAvery Dennison Belgie Bvba20140—
+4K112549IV Clear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and SilverCovalontechnologies, Inc.20120—
+5K240552Irrisept Antimicrobial Wound LavageIrrimax Corporation20240—
+5K221504BD Surgiphor™ Antimicrobial Irrigation SystemBd20222—
+5K222804Irrisept Antimicrobial Wound LavageIrrimax Corporation20220—
+6K253996BD Surgiphor™ Antimicrobial Irrigation System (910110)Becton, Dickinson and Company (BD)20260—
+6K253445BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)Bd20260—