Cleared Traditional

K990814 - CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15

K990814 is an FDA 510(k) clearance for CRYO CHECK FACTOR 2 DEFICIENT PLASMA, manufactured by Precision Biologic. The device is a Class 2 Hematology device with product code GJT cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K990814 · Precision Biologic · Hematology device
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Jun 1999
Decision
88d
Days
Class 2
Risk

K990814 is an FDA 510(k) clearance for the CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15. Classified as Plasma, Coagulation Factor Deficient (product code GJT), Class II - Special Controls.

Submitted by Precision Biologic (Dartmouth, N.S., CA). The FDA issued a Cleared decision on June 7, 1999 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7290 - 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 Precision Biologic devices

FDA 510(k) Submission Details - K990814

510(k) Number K990814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1999
Decision Date June 07, 1999
Days to Decision 88 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
25d faster than avg
Panel avg: 113d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GJT Device Classification - Class 2, Special Controls

Product Code GJT Plasma, Coagulation Factor Deficient
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7290
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 - GJT Plasma, Coagulation Factor Deficient

All 74
Devices cleared under the same product code (GJT) and FDA review panel - the closest regulatory comparables to K990814.
HEMOSIL FACTOR XI DEFICIENT PLASMA
K030287 · Instrumentation Laboratory CO · Mar 2003
HEMOSIL FACTOR VII DEFICIENT PLASMA
K024082 · Instrumentation Laboratory CO · Feb 2003
HEMOSIL FACTOR V DEFICIENT PLASMA
K023839 · Instrumentation Laboratory CO · Jan 2003
CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML)
K990296 · Precision Biologic · Mar 1999
PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA
K990046 · Pacific Hemostasis · Feb 1999
CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML)
K981173 · Precision Biologicals, Inc. · Jan 1999