Cleared Traditional

K991321 - PACIFIC HEMOSTASIS THROMBOSCREEN 200

K991321 is an FDA 510(k) clearance for PACIFIC HEMOSTASIS THROMBOSCREEN 200, manufactured by Pacific Hemostasis. The device is a Class 2 Hematology device with product code KQG cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K991321 · Pacific Hemostasis · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
63d
Days
Class 2
Risk

K991321 is an FDA 510(k) clearance for the PACIFIC HEMOSTASIS THROMBOSCREEN 200. Classified as Instrument, Coagulation (product code KQG), Class II - Special Controls.

Submitted by Pacific Hemostasis (Huntersville, US). The FDA issued a Cleared decision on June 21, 1999 after a review of 63 days - a notably fast clearance cycle.

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: 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 Pacific Hemostasis devices

FDA 510(k) Submission Details - K991321

510(k) Number K991321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1999
Decision Date June 21, 1999
Days to Decision 63 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 113d · This submission: 63d
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 7
Devices cleared under the same product code (KQG) and FDA review panel - the closest regulatory comparables to K991321.
COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM
K050821 · Zycare · Aug 2005
PACIFIC HEMOSTASIS THROMBOSCREEN 400C
K992130 · Pacific Hemostasis · Sep 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
ELVI BICLOT 816
K812906 · Volu Sol Medical Industries · Jul 1982