Cleared Traditional

K020297 - STAT PROFILE CRITICAL CARE XPRESS ANALYZER

K020297 is the FDA 510(k) clearance for STAT PROFILE CRITICAL CARE XPRESS ANALYZER by Nova Biomedical Corp.. It is a Class 2 Chemistry device (product code CHL) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K020297 · Nova Biomedical Corp. · Chemistry device
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Jun 2002
Decision
133d
Days
Class 2
Risk

K020297 is an FDA 510(k) clearance for the STAT PROFILE CRITICAL CARE XPRESS ANALYZER. Classified as Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (product code CHL), Class II - Special Controls.

Submitted by Nova Biomedical Corp. (Walham, US). The FDA issued a Cleared decision on June 10, 2002 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 Nova Biomedical Corp. devices

Submission Details

510(k) Number K020297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2002
Decision Date June 10, 2002
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.

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 107
Devices cleared under the same product code (CHL) and FDA review panel - the closest regulatory comparables to K020297.
STAT PROFILE CRITICAL CARE XPRESS ANALYZER
K022746 · Nova Biomedical Corp. · Nov 2002
STAT PROFILE PHOX PLUS C ANALYZER
K021713 · Nova Biomedical Corp. · Jul 2002
EASYSTAT PH, PCO2, PO2, HCT, NA+, K+, CA++ ANALYZER
K021515 · Medica Corp. · Jul 2002
STAT PROFILE PHOX ANALYZER
K014295 · Nova Biomedical Corp. · Feb 2002
STAT PROFILE PHOX BASIC ANALYZER
K013729 · Nova Biomedical Corp. · Jan 2002
STAT PROFILE PHOX PLUS L ANALYZER
K012058 · Nova Biomedical Corp. · Aug 2001