Cleared Traditional

K974396 - IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONA...

K974396 is the FDA 510(k) clearance for IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONA... by Diametrics Medical, Inc.. It is a Class 2 Hematology device (product code CHL) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K974396 · Diametrics Medical, Inc. · Hematology device
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Dec 1997
Decision
27d
Days
Class 2
Risk

K974396 is an FDA 510(k) clearance for the IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE .... Classified as Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (product code CHL), Class II - Special Controls.

Submitted by Diametrics Medical, Inc. (Roseville, US). The FDA issued a Cleared decision on December 18, 1997 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1120 - the FDA hematology device 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 Diametrics Medical, Inc. devices

Submission Details

510(k) Number K974396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1997
Decision Date December 18, 1997
Days to Decision 27 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 113d · This submission: 27d
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 Hematology devices follow this clearance model.

Regulatory Peers - CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph

All 119
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