Cleared Traditional

K833146 - AQUEOUS BLOOD GAS CONTROL

K833146 is an FDA 510(k) clearance for AQUEOUS BLOOD GAS CONTROL, manufactured by Bionostics, Inc.. The device is a Class 1 Chemistry device with product code JJS cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K833146 · Bionostics, Inc. · Chemistry device
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Nov 1983
Decision
74d
Days
Class 1
Risk

K833146 is an FDA 510(k) clearance for the AQUEOUS BLOOD GAS CONTROL. Classified as Controls For Blood-gases, (assayed And Unassayed) (product code JJS), Class I - General Controls.

Submitted by Bionostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 28, 1983 after a review of 74 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bionostics, Inc. devices

FDA 510(k) Submission Details - K833146

510(k) Number K833146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1983
Decision Date November 28, 1983
Days to Decision 74 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
14d faster than avg
Panel avg: 88d · This submission: 74d
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 57
Devices cleared under the same product code (JJS) and FDA review panel - the closest regulatory comparables to K833146.
MARQUEST QC-IV TONOMETER
K855024 · Marquest Medical Products, Inc. · Apr 1986
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 LEVEL I,II &
K832003 · American Dade · Aug 1983
CERTAIN HB CO-OXIMETER CONTROL
K832028 · Corning Medical & Scientific · Jul 1983
REFEREE BLOOD GAS ANALYZER CONTROLS
K830181 · Analytical Products, Inc. · Feb 1983