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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 1-155
Standard
ISO  10079-2 Fourth edition 2022-03
Medical suction equipment - Part 2: Manually powered suction equipment
Scope/Abstract
This document specifies safety and performance requirements for manually powered suction equipment intended for oro-pharyngeal suction. It applies to equipment operated by foot or by hand or both.

The commonest use of manually powered suction is in situations outside of healthcare settings often described as field use or transport use. Use in these situations may involve extreme conditions of weather or terrain. Additional/alternative requirements for manually powered suction equipment intended for field use or transport use are included in this document.

This document does not apply to mucus extractors.
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
§878.4680 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
§878.5040 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. 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
  FDA/OC/CDRH/OPEQ/OHTI/DHTIC/
  301-796-6471
  sidra.mirza@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Anesthesiology
*These are provided as examples and others may be applicable.
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