Cleared Traditional

K841783 - BLOOD GAS CONTROL

K841783 is the FDA 510(k) clearance for BLOOD GAS CONTROL by Bionostics, Inc.. It is a Class 1 Chemistry device (product code JJS) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K841783 · Bionostics, Inc. · Chemistry device

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Jun 1984

Decision

45d

Days

Class 1

Risk

K841783 is an FDA 510(k) clearance for the BLOOD GAS CONTROL, LEVEL I(ACIDOSIS. Classified as Controls For Blood-gases, (assayed And Unassayed) (product code JJS), Class I - General Controls.

Submitted by Bionostics, Inc. (Walker, US). The FDA issued a Cleared decision on June 14, 1984 after a review of 45 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

Submission Details

510(k) Number	K841783 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 30, 1984
Decision Date	June 14, 1984
Days to Decision	45 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

43d faster than avg

Panel avg: 88d · This submission: 45d

Pathway characteristics

Predicate-based equivalence.

Device Classification

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 25

Devices cleared under the same product code (JJS) and FDA review panel - the closest regulatory comparables to K841783.

CERTAIN(R) ELITE LEVEL 1, 2 AND 3

K946224 · Ciba Corning Diagnostics Corp. · Jan 1995

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

AQUEOUS BLOOD GAS CONTROL LEVEL I,II &

K832003 · American Dade · Aug 1983

CERTAIN HB CO-OXIMETER CONTROL

K832028 · Corning Medical & Scientific · Jul 1983

CORNING CERTAIN TM

K820873 · Corning Medical & Scientific · Apr 1982

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K841783

Bionostics, Inc.

Walker, MI · US

Regulatory profile

49 submissions 49 cleared

100% clearance rate · Active in Chemistry

Data Intelligence Layer

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Sourced from FDA 510(k) public files . Updated monthly.

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