Cleared Traditional

AVL OMNI ANALYZER (K954018) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K954018 · Avl Scientific Corp. · Hematology device
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Optimized for regulatory review, auditing and printing
Oct 1995
Decision
41d
Days
Class 2
Risk

K954018 is an FDA 510(k) clearance for the AVL OMNI ANALYZER. Classified as System, Hemoglobin, Automated (product code GKR), Class II - Special Controls.

Submitted by Avl Scientific Corp. (Roswell, US). The FDA issued a Cleared decision on October 5, 1995 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5620 - 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 Avl Scientific Corp. devices

Submission Details

510(k) Number K954018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1995
Decision Date October 05, 1995
Days to Decision 41 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 113d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKR System, Hemoglobin, Automated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5620
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 - GKR System, Hemoglobin, Automated

All 38
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