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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 040 Date of Entry 08/14/2015 
FR Recognition Number 10-96
ANSI  Z80.10-2014
American National Standard for Ophthalmics - Ophthalmic Instruments - Tonometers
This standard, together with ISO 15004-1:2009, Fundamental requirements and test methods - Part 1: General requirements applicable to all instruments - First edition, specifies minimum requirements and the design compliance procedure for tonometers intended for routine clinical use in the estimation of intraocular pressure (IOP) for the detection, diagnosis, and management of ocular abnormalities.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Within Annex B:
-B.5.3 (Last paragraph)
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§886.1930 Tonometer, Ac-Powered Class 2 HKX
§886.1930 Tonometer, Manual Class 2 HKY
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff: Tonometers - Premarket Notification [510(k)] Submissions, Issued March 27, 2006.

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
 Bruce Drum
Standards Development Organization
ANSI American National Standards Institute https://www.ansi.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.