Cleared Traditional

AMR RESEARCH TONOMETER (K862958) - FDA 510(k) Clearance

Class I Chemistry device.

K862958 · Associated Medical Representatives · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1986
Decision
111d
Days
Class 1
Risk

K862958 is an FDA 510(k) clearance for the AMR RESEARCH TONOMETER. Classified as Tonometer (calibration And Q.c. Of Blood-gas Instruments), Clinical (product code LCH), Class I - General Controls.

Submitted by Associated Medical Representatives (Denver, US). The FDA issued a Cleared decision on November 24, 1986 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Associated Medical Representatives devices

Submission Details

510(k) Number K862958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1986
Decision Date November 24, 1986
Days to Decision 111 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 88d · This submission: 111d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCH Tonometer (calibration And Q.c. Of Blood-gas Instruments), Clinical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.