[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-QKM":3},{"classification":4,"mappedDevices":42,"relatedClassifications":43,"syncDates":67},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":10,"submission_type_id":12,"definition":13,"implant_flag":14,"life_sustain_support_flag":14,"gmp_exempt_flag":14,"raw":15,"created_at":37,"updated_at":38,"recall_count":39,"latest_recall_date":40,"k510_count":41,"pma_count":39,"event_count":39},7041,"QKM","A Chemical Vapor Sterilization Multivariable Chemical Indicator","2","880.2800","HO","General Hospital","1","A chemical vapor sterilization multivariable chemical indicator monitors two or more  parameters of a chemical vapor sterilization process.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":34,"device_class":8,"implant_flag":35,"product_code":6,"review_panel":10,"gmp_exempt_flag":35,"third_party_flag":35,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":34,"life_sustain_support_flag":35,"medical_specialty_description":11,"summary_malfunction_reporting":36},{"k_number":17,"fei_number":23,"registration_number":32},[18,19,20,21,22],"K232103","K213262","K203284","K212022","K193110",[24,25,26,27,28,29,30,31],"3013145340","3031757047","3004080920","3015392401","3000251274","3042272797","3001168737","3031841433",[24,25,26,27,28,29,31,33],"8021896","","N","Ineligible","2026-08-18T05:52:53.878886+00:00","2026-08-18T22:05:38.961415+00:00",0,null,5,[],[44,48,52,55,59,63],{"product_code":45,"device_name":46,"device_class":8,"k510_count":47},"JOJ","Indicator, Physical\u002FChemical Sterilization Process",264,{"product_code":49,"device_name":50,"device_class":8,"k510_count":51},"FRC","Indicator, Biological Sterilization Process",206,{"product_code":53,"device_name":54,"device_class":8,"k510_count":41},"LRT","Indicator, Sterilization",{"product_code":56,"device_name":57,"device_class":8,"k510_count":58},"MRB","Indicator, Biological, Liquid Chemical Sterilization Process",4,{"product_code":60,"device_name":61,"device_class":8,"k510_count":62},"MTC","Indicator, Chemical, Enzymatic, Sterilization Process",2,{"product_code":64,"device_name":65,"device_class":8,"k510_count":66},"OCI","Indicator, Physical\u002FChemical, Storage Temperature",1,{"510k":68,"classification":69,"enforcement":70,"event":71,"pma":72,"warning_letter":73},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-18T22:42:53.076+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]