• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 049 Date of Recognition 06/07/2018 
FR Recognition Number 1-132
Standard
ISO 10079-2 Third Edition 2014-05-01
Medical suction equipment - Part 2: Manually powered suction equipment
Scope/Abstract
ISO 10079-2:2014 specifies safety and performance requirements for medical, manually powered suction equipment intended for oro-pharyngeal suction. It covers equipment operated by foot or by hand or both. Annex C illustrates the three parts of ISO 10079 by providing a schematic for typical systems.

ISO 10079-2:2014 has additional requirements for suction equipment intended for field use or transport use.

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 Regulator, Vacuum Class 2 KDP
§878.5040 System, Suction, Lipoplasty Class 2 MUU
§878.4780 Pump, Portable, Aspiration (Manual Or Powered) Class 2 BTA
§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
§874.5350 Device, Antichoke, Suction Class 3 EWT
§870.5910 Esophageal Thermal Regulation And Gastric Suctioning Device Class 2 PLA
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
-
-