Cleared Traditional

K840300 - FLUSH SOLUTION CONCENTRATE-BLOOD GAS

K840300 is the FDA 510(k) clearance for FLUSH SOLUTION CONCENTRATE-BLOOD GAS by Bionostics, Inc.. It is a Class 2 Chemistry device (product code CHL) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K840300 · Bionostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1984
Decision
59d
Days
Class 2
Risk

K840300 is an FDA 510(k) clearance for the FLUSH SOLUTION CONCENTRATE-BLOOD GAS. Classified as Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (product code CHL), Class II - Special Controls.

Submitted by Bionostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 23, 1984 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1120 - 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 K840300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1984
Decision Date March 23, 1984
Days to Decision 59 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 88d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1120
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph

All 85
Devices cleared under the same product code (CHL) and FDA review panel - the closest regulatory comparables to K840300.
LIFE WATCH RESPIRATORY MONITOR
K853840 · The Perkin-Elmer Corp. · Dec 1985
ANALYZER NOVA STAT PROFILE 2/QUALITY CONTROL MAT.
K854608 · Nova Biomedical Corp. · Dec 1985
ANALYZER: NOVA STAT PROFILE 1 QUA CON MAT: ELECT
K852790 · Nova Biomedical Corp. · Nov 1985
CALIBRATING SOLUTION FOR ABL-1 & 2
K831018 · Fisher Scientific Co., LLC · Jun 1983
PH 6.838 REF. BUFFER
K831019 · Fisher Scientific Co., LLC · Jun 1983
CALIBRATING SOLUTION FOR ABL-1 & 2
K831021 · Fisher Scientific Co., LLC · Jun 1983