Cleared Special

ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE (K992859) - FDA 510(k) Clearance

Class II Chemistry device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K992859 · Radiometer America, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
138d
Days
Class 2
Risk

K992859 is an FDA 510(k) clearance for the ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE. 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 10, 2000 after a review of 138 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Radiometer America, Inc. devices

Submission Details

510(k) Number K992859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1999
Decision Date January 10, 2000
Days to Decision 138 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 88d · This submission: 138d
Pathway characteristics
Modification to existing cleared device.

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 K992859.
GEM PREMIER 4000 WITH IQM, MODEL 4000
K061974 · Instrumentation Laboratory CO · Sep 2006
OMNI MODULAR, OMNI C AND OMNI S ANALYZER (PH ELECTRODE)
K050423 · Roche Diagnostics · Apr 2005
BAYER RAPIDPOINT 400 SYSTEM
K002738 · Bayer Corp. · Dec 2000
GEM PREMIER 3000
K992834 · Instrumentation Laboratory CO · Nov 1999
IL SYNTHESIS
K963800 · Instrumentation Laboratory CO · Nov 1996
CIBA CORNING 400 SYSTEM
K961657 · Ciba Corning Diagnostics Corp. · Jun 1996