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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 1-158
ISO  10079-4 First edition 2021-08
Medical suction equipment - Part 4: General requirements
This document specifies general requirements for medical suction equipment that are common to all parts of the ISO 10079 series.
This document is not applicable to the following:
a) end-pieces such as suction catheters, drains, curettes, Yankauer suckers and suction tips;
b) syringes;
c) dental suction equipment;
d) anaesthetic gas scavenging systems;
e) laboratory suction;
f) autotransfusion systems;
g) mucus extractors including neonatal mucus extractors;
h) suction equipment where the collection container is downstream of the vacuum pump;
i) ventouse (obstetric) equipment;
j) suction equipment marked for endoscopic use only; and
k) plume evacuation systems.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports 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
§876.1500 Endoscopic Irrigation/Suction System Class 2 OCX
§878.4680 Apparatus, Suction, Single Patient Use, Portable, Nonpowered Class 1 GCY
§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 Apparatus, Suction, Ward Use, Portable, Ac-Powered Class 2 JCX
§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 Regulator, Vacuum Class 2 KDP
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. ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)].

3. ISO 5356-1 Third edition 2004-05 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets.

4. ISO 10993-1 Fifth edition 2018-08 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.

5. IEC 62366-1 Edition 1.1 2020-06 Medical devices - Part 1: Application of usability engineering to medical devices.

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.