Cleared Traditional

K902267 - BLOOD GASES/PC02

K902267 is an FDA 510(k) clearance for BLOOD GASES/PC02, manufactured by Phoenix Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code CHL cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K902267 · Phoenix Diagnostics, Inc. · Chemistry device
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Jun 1990
Decision
22d
Days
Class 2
Risk

K902267 is an FDA 510(k) clearance for the BLOOD GASES/PC02, PO2 ANALYSIS PRODUCTS. Classified as Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (product code CHL), Class II - Special Controls.

Submitted by Phoenix Diagnostics, Inc. (Medfield, US). The FDA issued a Cleared decision on June 12, 1990 after a review of 22 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 Phoenix Diagnostics, Inc. devices

FDA 510(k) Submission Details - K902267

510(k) Number K902267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1990
Decision Date June 12, 1990
Days to Decision 22 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 88d · This submission: 22d
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 151
Devices cleared under the same product code (CHL) and FDA review panel - the closest regulatory comparables to K902267.
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