510(k) Report

Devices descending from K202641

7 later devices reach DNA/RNA Shield Collection Tube through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242820Puritan PurSafe Plus Collection and Transport SystemPuritan Medical Products, LLC20250—
+1K221547InActiv BlueFertipro NV20240—
+1K231013DNA/RNA Shield SafeCollect Saliva Collection kitZymo Research20230—
+1K221802iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)Mawi Dna Technologies20230—
+1K223497Spectrum Saliva Collection DeviceSpectrum Solutions, LLC20231—
+1K211675Dasky Disposable Sampling Tube (Model name: VSM02)Ningbo Dasky Life Science Co., Ltd.20220—
+2K240797PPH Saliva Collection KitPermantis Public Health20240—