Cleared Traditional

K012058 - STAT PROFILE PHOX PLUS L ANALYZER

K012058 is the FDA 510(k) clearance for STAT PROFILE PHOX PLUS L ANALYZER by Nova Biomedical Corp.. It is a Class 2 Chemistry device (product code CHL) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K012058 · Nova Biomedical Corp. · Chemistry device
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Aug 2001
Decision
49d
Days
Class 2
Risk

K012058 is an FDA 510(k) clearance for the STAT PROFILE PHOX PLUS L 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 August 20, 2001 after a review of 49 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 Nova Biomedical Corp. devices

Submission Details

510(k) Number K012058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2001
Decision Date August 20, 2001
Days to Decision 49 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
39d faster than avg
Panel avg: 88d · This submission: 49d
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 K012058.
STAT PROFILE CRITICAL CARE XPRESS ANALYZER
K020297 · Nova Biomedical Corp. · Jun 2002
STAT PROFILE PHOX ANALYZER
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STAT PROFILE PHOX BASIC ANALYZER
K013729 · Nova Biomedical Corp. · Jan 2002
BAYER RAPIDPOINT 400 SYSTEM
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K002613 · Nova Biomedical Corp. · Oct 2000
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K992859 · Radiometer America, Inc. · Jan 2000