Cleared Traditional

K021976 - FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON

K021976 is an FDA 510(k) clearance for FIBRON-1, manufactured by Vital Scientific N.V.. The device is a Class 2 Hematology device with product code KQG cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K021976 · Vital Scientific N.V. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
130d
Days
Class 2
Risk

K021976 is an FDA 510(k) clearance for the FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON. Classified as Instrument, Coagulation (product code KQG), Class II - Special Controls.

Submitted by Vital Scientific N.V. (Newton, US). The FDA issued a Cleared decision on October 25, 2002 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5400 - 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 Vital Scientific N.V. devices

FDA 510(k) Submission Details - K021976

510(k) Number K021976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2002
Decision Date October 25, 2002
Days to Decision 130 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
17d slower than avg
Panel avg: 113d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KQG Device Classification - Class 2, Special Controls

Product Code KQG Instrument, Coagulation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5400
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 - KQG Instrument, Coagulation

All 8
Devices cleared under the same product code (KQG) and FDA review panel - the closest regulatory comparables to K021976.
COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM
K050821 · Zycare · Aug 2005
PACIFIC HEMOSTASIS THROMBOSCREEN 400C
K992130 · Pacific Hemostasis · Sep 1999
PACIFIC HEMOSTASIS THROMBOSCREEN 200
K991321 · Pacific Hemostasis · Jun 1999
HEMOCHRON RESPONSE
K983475 · International Technidyne Corp. · May 1999
ELECTRA 800 AUTOMATIC COAGULATION TIMER
K851169 · Medical Laboratory Automation Systems, Inc. · Jun 1985
KOAGULAB 40-A AUTOMATED COAGULATION SYS
K823131 · Ortho Diagnostic Systems, Inc. · Dec 1982