Cleared Traditional

K002290 - ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS)

K002290 is an FDA 510(k) clearance for ABL-700 SERIES, manufactured by Radiometer Medical A/S. The device is a Class 2 Chemistry device with product code CHL cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K002290 · Radiometer Medical A/S · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2000
Decision
48d
Days
Class 2
Risk

K002290 is an FDA 510(k) clearance for the ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS). Classified as Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (product code CHL), Class II - Special Controls.

Submitted by Radiometer Medical A/S (Bronshoj, DK). The FDA issued a Cleared decision on September 13, 2000 after a review of 48 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 Radiometer Medical A/S devices

FDA 510(k) Submission Details - K002290

510(k) Number K002290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2000
Decision Date September 13, 2000
Days to Decision 48 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 88d · This submission: 48d
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 160
Devices cleared under the same product code (CHL) and FDA review panel - the closest regulatory comparables to K002290.
STAT PROFILE PHOX PLUS L ANALYZER
K012058 · Nova Biomedical Corp. · Aug 2001
BAYER RAPIDPOINT 400 SYSTEM
K002738 · Bayer Corp. · Dec 2000
MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZER
K002613 · Nova Biomedical Corp. · Oct 2000
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