510(k) Report

Devices descending from K191021

9 later devices reach Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251991SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure…Shenzhen Safesecure Medical Infection Control Tech Co., Ltd.20250—
+1K242860Type 5 Integrating Indicator for Steam (CSPN-15)True Indicating, LLC20250—
+1K242453Terragene® Bionova® Photon Process Challenge Device with unique-point integrator…Terragene S.A.20240—
+1K222137OK Plus IndicatorPropper Manufacturing Co., Inc.20220—
+1K212592Gas-Chex IndicatorPropper Manufacturing Co., Inc.20220—
+1K212193Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD…Plasmapp Co,., Ltd.20213—
+2K231169STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK…Plasmapp Co,., Ltd.20230—
+2K223023Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD…Plasmapp Co,., Ltd.20230—
+2K220345STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK…Plasmapp Co,., Ltd.20230—