Cleared Traditional

K952720 - AALTO SCIENTIFIC LTD. GLYCATED HEMOGLOB...

K952720 is the FDA 510(k) clearance for AALTO SCIENTIFIC LTD. GLYCATED HEMOGLOB... by Aalto Scientific, Ltd.. It is a Class 2 Hematology device (product code JPK) cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K952720 · Aalto Scientific, Ltd. · Hematology device
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Sep 1995
Decision
97d
Days
Class 2
Risk

K952720 is an FDA 510(k) clearance for the AALTO SCIENTIFIC LTD. GLYCATED HEMOGLOBIN CONTROL LEVELS I & II. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by Aalto Scientific, Ltd. (Vista, US). The FDA issued a Cleared decision on September 20, 1995 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8625 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K952720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1995
Decision Date September 20, 1995
Days to Decision 97 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
16d faster than avg
Panel avg: 113d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JPK Mixture, Hematology Quality Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8625
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 - JPK Mixture, Hematology Quality Control

All 117
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K952720.
R&D RETIC-PG HEMATOLOGY CONTROL
K961673 · R&D Systems, Inc. · Jul 1996
CALIBRATION VERIFICATION ASSESSMENT (CVA)
K960557 · Streck Laboratories, Inc. · Apr 1996
QBC CENTRIFUGAL HEMATOLOGY CONTROL
K954137 · R&D Systems, Inc. · Oct 1995
SF-CHECK
K952245 · Streck Laboratories, Inc. · Sep 1995
RETIC CONTROL-M HEMATOLOGY CONTROL/MULTIPLE
K943335 · R&D Systems, Inc. · Dec 1994
RETIC CONTROL-H HEMATOLOGY CONTROL/MULTIPLE
K943336 · R&D Systems, Inc. · Dec 1994