Cleared Traditional

K913128 - HEMATASTAT C-70B

K913128 is an FDA 510(k) clearance for HEMATASTAT C-70B, manufactured by Separation Technology, Inc.. The device is a Class 2 Hematology device with product code GKG cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K913128 · Separation Technology, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1991
Decision
136d
Days
Class 2
Risk

K913128 is an FDA 510(k) clearance for the HEMATASTAT C-70B. Classified as Centrifuge, Hematocrit (product code GKG), Class II - Special Controls.

Submitted by Separation Technology, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on September 23, 1991 after a review of 136 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.6400 - 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 Separation Technology, Inc. devices

FDA 510(k) Submission Details - K913128

510(k) Number K913128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1991
Decision Date September 23, 1991
Days to Decision 136 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
23d slower than avg
Panel avg: 113d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKG Device Classification - Class 2, Special Controls

Product Code GKG Centrifuge, Hematocrit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.6400
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 - GKG Centrifuge, Hematocrit

All 7
Devices cleared under the same product code (GKG) and FDA review panel - the closest regulatory comparables to K913128.
MULTI-CENTRIFUGE
K955795 · Novonx, Inc. · Mar 1996
MICROHEMATOCRIT ROTOR
K930415 · Fisher Scientific Co., LLC · Mar 1993
SPUNCRIT
K925863 · bioMerieux, Inc. · Feb 1993
QBC CENTRIFUGAL HEMATOLOGY SYSTEM
K821803 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1982
HCT CENTRIFUGE
K822445 · Boehringer Mannheim Corp. · Sep 1982
CLAY ADAMS QBC CENTRIFUGAL HEMOTOLOGY
K813033 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1982