Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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049
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Date of Entry 06/07/2018
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FR Recognition Number
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1-132
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Standard | |
ISO 10079-2 Third Edition 2014-05-01 Medical suction equipment - Part 2: Manually powered suction equipment |
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Scope/AbstractISO 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.
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Extent of Recognition
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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. |
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Transition Period
FDA recognition of ISO 10079-2 Third edition 2014-05 [Rec# 1-132] will be superseded by recognition of ISO 10079-2 Fourth edition 2022-03 [Rec# 1-155]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 1-132] until December 17, 2023. After this transition period, declarations of conformity to [Rec# 1-132] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§870.5910 |
Esophageal Thermal Regulation And Gastric Suctioning Device
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Class 2
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PLA
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§874.5350 |
Device, Antichoke, Suction
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Class 3
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EWT
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§878.4680 |
Apparatus, Suction, Single Patient Use, Portable, Nonpowered
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Class 1
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GCY
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§878.4683 |
Negative Pressure Wound Therapy Non-Powered Suction Apparatus
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Class 2
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OKO
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§878.4780 |
Pump, Portable, Aspiration (Manual Or Powered)
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Class 2
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BTA
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§878.5040 |
System, Suction, Lipoplasty
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Class 2
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MUU
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§878.5040 |
System, Suction, Lipoplasty For Removal
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Class 2
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QPB
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§880.6740 |
Regulator, Vacuum
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Class 2
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KDP
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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.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |