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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 059 Date of Entry 12/19/2022 
FR Recognition Number 1-156
ISO  10079-3 Fourth edition 2022-03
Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source
This document specifies basic safety and performance requirements for medical suction equipment powered from a vacuum or positive pressure gas source generating venturi suction. It applies to suction equipment connected to medical gas pipeline systems or cylinders and venturi attachments and can be standalone 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
§870.5050 Apparatus, Suction, Patient Care Class 2 DWM
§870.5910 Esophageal Thermal Regulation And Gastric Suctioning Device Class 2 PLA
§874.5350 Device, Antichoke, Suction Class 3 EWT
§878.4683 Negative Pressure Wound Therapy Non-Powered Suction Apparatus Class 2 OKO
§878.4780 Pump, Portable, Aspiration (Manual Or Powered) Class 2 BTA
§878.4780 Vacuum Powered Body Fluid Collection Kit Class 2 OJR
§878.4780 Negative Pressure Wound Therapy Powered Suction Pump Class 2 OMP
§878.4780 Wound Drain Catheter System Class 2 OTK
§878.5040 System, Suction, Lipoplasty Class 2 MUU
§878.5040 System, Suction, Lipoplasty For Removal Class 2 QPB
§880.6740 Bottle, Collection And Trap, Breathing System (Uncalibrated) Class 2 CBC
§880.6740 Apparatus, Suction, Operating-Room, Wall Vacuum Powered Class 2 GCX
§880.6740 Regulator, Vacuum Class 2 KDP
§880.6740 Bottle, Collection, Vacuum Class 2 KDQ
§880.6740 Chest Drainage Kit Class 2 PAD
Relevant FDA Guidance and/or Supportive Publications*
1. Guidance for Industry and FDA Reviewers/Staff: Guidance Document for Powered Suction Pump 510(k)s, issued September 1998.

2. ISO 5359 Fourth edition 2014-10 Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases [Including AMENDMENT 1 (2017)].

3. ISO 10079-4 First edition 2021-08 Medical suction equipment - Part 4: General requirements.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Sidra Mirza
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.