Cleared Traditional

K914166 - ABL505 BLOOD GAS & ELECTROLYTE SYSTEM

K914166 is an FDA 510(k) clearance for ABL505 BLOOD GAS & ELECTROLYTE 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 133-day FDA review.

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

FDA 510(k) Submission Details - K914166

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
Combination Product No
PCCP Authorized No
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.

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 K914166.
STAT PROFILE 9 ANALYZER
K924497 · Nova Biomedical Corp. · Feb 1993
STATPAL II BLOOD GAS ANALYSIS SYSTEM
K922631 · Ppg Industries, Inc. · Nov 1992
ABL50 BLOOD GAS SYSTEM
K922922 · Radiometer America, Inc. · Aug 1992
STAT PAL SENSYR SYRINGE ASSEMBLY FOR USE W/STATPAL
K914560 · Ppg Industries, Inc. · Nov 1991
IL BG3 SYST, MODEL 1420, BLOOD GAS & PH TEST SYST
K913927 · Instrumentation Laboratory CO · Oct 1991
STATPAL BLOOD GAS MONITORING SYSTEM
K903965 · Ppg Industries, Inc. · Dec 1990