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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 058 Date of Entry 05/30/2022 
FR Recognition Number 6-481
ANSI AAMI  CN27:2021
General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications
This standard covers Luer activated valves (LAVs) for intravascular applications, which open and permit access to the fluid conduit when a male Luer connector is inserted.

This standard applies only to the valve end of LAVs.

This standard applies to LAVs as stand-alone devices or as components of a medical device.

This standard does not address valves that are opened by a female Luer connector.

This standard does not address the connection features of the non-valve end of LAVs and/or other integrated features (e.g., stopcock handles) (Figure 1).
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§880.5440 Stopcock, I.V. Set Class 2 FMG
§880.5440 Set, Administration, Intravascular Class 2 FPA
§880.5440 Set, I.V. Fluid Transfer Class 2 LHI
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff - Intravascular Administration Sets Premarket Notification Submissions [510(k)], issued July 11, 2008.

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 Contacts
 David Wolloscheck
 Sreya Tarafdar
Standards Development Organizations
ANSI American National Standards Institute https://www.ansi.org/
AAMI Association for the Advancement of Medical Instrumentation http://www.aami.org
FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital
*These are provided as examples and others may be applicable.