Cleared Traditional

K925528 - BIOVATION K-MANAGER

K925528 is an FDA 510(k) clearance for BIOVATION K-MANAGER, manufactured by Biovation, Inc.. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K925528 · Biovation, Inc. · Hematology device
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Feb 1993
Decision
95d
Days
Class 2
Risk

K925528 is an FDA 510(k) clearance for the BIOVATION K-MANAGER. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Biovation, Inc. (Hercules, US). The FDA issued a Cleared decision on February 5, 1993 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5220 - 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.

View all Biovation, Inc. devices

FDA 510(k) Submission Details - K925528

510(k) Number K925528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1992
Decision Date February 05, 1993
Days to Decision 95 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
18d faster than avg
Panel avg: 113d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKZ Device Classification - Class 2, Special Controls

Product Code GKZ Counter, Differential Cell
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5220
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 - GKZ Counter, Differential Cell

All 304
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K925528.
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K921279 · Coulter Electronics, Inc. · Dec 1992
TECHNICON H*2
K923237 · Heraeus Kulzer, Inc. · Sep 1992