Cleared Traditional

K935655 - ABL5 BLOOD GAS SYSTEM

K935655 is an FDA 510(k) clearance for ABL5 BLOOD GAS SYSTEM, manufactured by Radiometer America, Inc.. The device is a Class 2 Chemistry device with product code CHL cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K935655 · Radiometer America, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
184d
Days
Class 2
Risk

K935655 is an FDA 510(k) clearance for the ABL5 BLOOD GAS 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 May 27, 1994 after a review of 184 days - an extended review 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: 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

FDA 510(k) Submission Details - K935655

510(k) Number K935655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1993
Decision Date May 27, 1994
Days to Decision 184 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
96d slower than avg
Panel avg: 88d · This submission: 184d
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 151
Devices cleared under the same product code (CHL) and FDA review panel - the closest regulatory comparables to K935655.
AVL COMPACT 1 PH/BLOOD GAS ANALYZER
K943570 · Avl Scientific Corp. · Aug 1994
AVL COMPACT 2 PH/BLOOD GAS ANALYZER
K942616 · Avl Scientific Corp. · Jul 1994
ABL SYSTEM 620
K935121 · Radiometer America, Inc. · May 1994
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