510(k) Report

Devices descending from K030004

6 later devices reach 0.55% Orth-Phthalaldehyde Solution through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160921CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical…Cs Medical, LLC20162—
+1K120306Rapicide Opa-28Minntech Corp.20123—
+1K070627Opaciden SolutionCiden Technologies, LLC20075—
+2K192228CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12…Cs Medical, LLC20201—
+2K140703Opa 30 SolutionCiden Technologies, LLC20140—
+3K233049TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with…Cs Medical, LLC20230—