Cleared Traditional

K993789 - CLINICAL BLOOD GAS MIXTURE

K993789 is an FDA 510(k) clearance for CLINICAL BLOOD GAS MIXTURE, manufactured by General Air Service and Supply. The device is a Class 2 Chemistry device with product code CHL cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K993789 · General Air Service and Supply · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
62d
Days
Class 2
Risk

K993789 is an FDA 510(k) clearance for the CLINICAL BLOOD GAS MIXTURE. Classified as Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (product code CHL), Class II - Special Controls.

Submitted by General Air Service and Supply (Commerce City, US). The FDA issued a Cleared decision on January 10, 2000 after a review of 62 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 General Air Service and Supply devices

FDA 510(k) Submission Details - K993789

510(k) Number K993789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1999
Decision Date January 10, 2000
Days to Decision 62 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 88d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CHL Device Classification - Class 2, Special Controls

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 157
Devices cleared under the same product code (CHL) and FDA review panel - the closest regulatory comparables to K993789.
AVL OPTI R ANALYZER
K000103 · Avl Scientific Corp. · Mar 2000
ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM
K994346 · Sendx Medical, Inc. · Feb 2000
ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE
K992859 · Radiometer America, Inc. · Jan 2000
ABL 735 ANALYZER
K991417 · Radiometer America, Inc. · Nov 1999
GEM PREMIER 3000
K992834 · Instrumentation Laboratory CO · Nov 1999
AVL OMNI MODULAR ANALYZER
K990092 · Avl Scientific Corp. · Jan 1999