Cleared Traditional

K855024 - MARQUEST QC-IV TONOMETER

K855024 is an FDA 510(k) clearance for MARQUEST QC-IV TONOMETER, manufactured by Marquest Medical Products, Inc.. The device is a Class 1 Chemistry device with product code JJS cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K855024 · Marquest Medical Products, Inc. · Chemistry device
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Apr 1986
Decision
111d
Days
Class 1
Risk

K855024 is an FDA 510(k) clearance for the MARQUEST QC-IV TONOMETER. Classified as Controls For Blood-gases, (assayed And Unassayed) (product code JJS), Class I - General Controls.

Submitted by Marquest Medical Products, Inc. (Englewood, US). The FDA issued a Cleared decision on April 7, 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 Marquest Medical Products, Inc. devices

FDA 510(k) Submission Details - K855024

510(k) Number K855024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1985
Decision Date April 07, 1986
Days to Decision 111 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 88d · This submission: 111d
Pathway characteristics
Predicate-based equivalence.

JJS Device Classification - Class 1, General Controls

Product Code JJS Controls For Blood-gases, (assayed And Unassayed)
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.

Regulatory Peers - JJS Controls For Blood-gases, (assayed And Unassayed)

All 48
Devices cleared under the same product code (JJS) and FDA review panel - the closest regulatory comparables to K855024.
MULTI-FUNCTION BLOOD GAS CONTROL
K874408 · Bionostics, Inc. · Dec 1987
AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III
K872196 · American Dade · Jul 1987
BAYER HEALTHCARE RAPIDQC PLUS
K870036 · Ciba Corning Diagnostics Corp. · Jan 1987
MULTI FUNCTION BLOOD GAS CONTROL
K851911 · Bionostics, Inc. · May 1985
BLOOD GAS CONTROL, LEVEL I(ACIDOSIS
K841783 · Bionostics, Inc. · Jun 1984
AQUEOUS BLOOD GAS CONTROL
K833146 · Bionostics, Inc. · Nov 1983