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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 049 Date of Recognition 06/07/2018 
FR Recognition Number 1-133
Standard
ISO 10079-3 Third Edition 2014-05-01
Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source
Scope/Abstract
ISO 10079-3:2014 specifies safety and performance requirements for medical suction equipment powered from a vacuum or positive pressure gas source generating venturi suction. It applies to equipment connected to medical gas pipeline systems or cylinders and venturi attachments.

The equipment can be stand-alone or part of an integrated system.

Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized because it is scientifically and technically valid and not in conflict with existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§880.6740 Apparatus, Suction, Operating-Room, Wall Vacuum Powered Class 2 GCX
§880.6740 Bottle, Collection And Trap, Breathing System (Uncalibrated) Class 2 CBC
§880.6740 Bottle, Collection, Breathing System (Calibrated) Class 2 CBD
§880.6740 Bottle, Collection, Vacuum Class 2 KDQ
§880.6740 Chest Drainage Kit Class 2 PAD
§880.6740 Regulator, Vacuum Class 2 KDP
§878.5040 System, Suction, Lipoplasty Class 2 MUU
§878.4780 Negative Pressure Wound Therapy Powered Suction Pump Class 2 OMP
§878.4780 Pump, Portable, Aspiration (Manual Or Powered) Class 2 BTA
§878.4780 Vacuum Powered Body Fluid Collection Kit Class 2 OJR
§878.4780 Wound Drain Catheter System Class 2 OTK
§874.5350 Device, Antichoke, Suction Class 3 EWT
§870.5910 Esophageal Thermal Regulation And Gastric Suctioning Device Class 2 PLA
§870.5050 Apparatus, Suction, Patient Care Class 2 DWM
Relevant FDA Guidance and/or Supportive Publications
Guidance for Industry and FDA Reviewers/Staff: Guidance Document for Powered Suction Pump 510(k)s. Issued September 1998.
FDA Technical Contacts
 Sidra Mirza
  FDA/OMPT/CDRH/ODE/DAGID/RPDB/
  301-796-6471
  sidra.mirza@fda.hhs.gov
 Brandon Blakley
  FDA/OMPT/CDRH/ODE/DAGRID/RPDB
  301-348-1958
  brandon.blakely@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Anesthesiology
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