Cleared Traditional

ABL505 BLOOD GAS & ELECTROLYTE SYSTEM (K914166) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K914166 · Radiometer America, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1992
Decision
133d
Days
Class 2
Risk

K914166 is an FDA 510(k) clearance for the ABL505 BLOOD GAS & ELECTROLYTE SYSTEM. Classified as Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (product code CHL), Class II - Special Controls.

Submitted by Radiometer America, Inc. (Westlake, US). The FDA issued a Cleared decision on January 28, 1992 after a review of 133 days - within the typical 510(k) review window.

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: 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 Radiometer America, Inc. devices

Submission Details

510(k) Number K914166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1991
Decision Date January 28, 1992
Days to Decision 133 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 88d · This submission: 133d
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 47
Devices cleared under the same product code (CHL) and FDA review panel - the closest regulatory comparables to K914166.
IL1430 BGELECTROLYTE ANALYZER
K935069 · Instrumentation Laboratory CO · Mar 1994
CIBA CORNING 248 PH/BLOOD GAS ANALYZER
K935830 · Ciba Corning Diagnostics Corp. · Feb 1994
860 MEASURMENT SYSTEM
K934907 · Ciba Corning Diagnostics Corp. · Jan 1994
IL BG3 SYST, MODEL 1420, BLOOD GAS & PH TEST SYST
K913927 · Instrumentation Laboratory CO · Oct 1991
CIBA CORNING MODEL 238 PH/ BLOOD GAS ANALYZER
K904188 · Ciba Corning Diagnostics Corp. · Sep 1990
IL1400, BGELECTROLYTE ANALYZER
K890827 · Instrumentation Laboratory CO · Jun 1989