| Part B: Supplementary Information Sheet (SIS) |
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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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1-133
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| Standard | |
ISO 10079-3 Third Edition 2014-05-01
Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source |
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Scope/AbstractISO 10079-3:2014 specifies safety and performance requirements for medical suction equipment powered from a vacuum or positive pressure gas source generating venturi suction. It applies to equipment connected to medical gas pipeline systems or cylinders and venturi attachments.
The equipment can be stand-alone or part of an integrated system.
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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| FDA recognition of ISO 10079-3 Third edition 2014-05 [Rec# 1-133] will be superseded by recognition of ISO ISO 10079-3 Fourth edition 2022-03 [Rec# 1-156]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 1-133] until December 17, 2023. After this transition period, declarations of conformity to [Rec# 1-133] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §870.5050 |
Apparatus, Suction, Patient Care
|
Class 2
|
DWM
|
| §870.5910 |
Esophageal Thermal Regulation And Gastric Suctioning Device
|
Class 2
|
PLA
|
| §874.5350 |
Device, Antichoke, Suction
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Class 3
|
EWT
|
| §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
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MUU
|
| §878.5040 |
System, Suction, Lipoplasty For Removal
|
Class 2
|
QPB
|
| §880.6740 |
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
|
Class 2
|
GCX
|
| §880.6740 |
Bottle, Collection And Trap, Breathing System (Uncalibrated)
|
Class 2
|
CBC
|
| §880.6740 |
Bottle, Collection, Breathing System (Calibrated)
|
Class 2
|
CBD
|
| §880.6740 |
Chest Drainage Kit
|
Class 2
|
PAD
|
| §880.6740 |
Regulator, Vacuum
|
Class 2
|
KDP
|
| §880.6740 |
Bottle, Collection, Vacuum
|
Class 2
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KDQ
|
|
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. |
