Cleared Traditional

K936203 - STAT PROFILE PLUS 10 ANALYZER

K936203 is the FDA 510(k) clearance for STAT PROFILE PLUS 10 ANALYZER by Nova Biomedical Corp.. It is a Class 2 Chemistry device (product code CHL) cleared through the Traditional 510(k) pathway after a 443-day FDA review.

K936203 · Nova Biomedical Corp. · Chemistry device
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Mar 1995
Decision
443d
Days
Class 2
Risk

K936203 is an FDA 510(k) clearance for the STAT PROFILE PLUS 10 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 March 9, 1995 after a review of 443 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Nova Biomedical Corp. devices

Submission Details

510(k) Number K936203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1993
Decision Date March 09, 1995
Days to Decision 443 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
355d slower than avg
Panel avg: 88d · This submission: 443d
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
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