Cleared Traditional

K791022 - PROTHROMBIN REFERENCE PLASMA (HUMAN)

K791022 is an FDA 510(k) clearance for PROTHROMBIN REFERENCE PLASMA (HUMAN), manufactured by Pacific Hemostasis. The device is a Class 2 Hematology device with product code GJS cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K791022 · Pacific Hemostasis · Hematology device
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Jul 1979
Decision
55d
Days
Class 2
Risk

K791022 is an FDA 510(k) clearance for the PROTHROMBIN REFERENCE PLASMA (HUMAN). Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by Pacific Hemostasis (Mchenry, US). The FDA issued a Cleared decision on July 24, 1979 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7750 - 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 - K791022

510(k) Number K791022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1979
Decision Date July 24, 1979
Days to Decision 55 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 113d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GJS Device Classification - Class 2, Special Controls

Product Code GJS Test, Time, Prothrombin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7750
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 - GJS Test, Time, Prothrombin

All 113
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K791022.
SIGMA PROCEDURE #890
K811784 · Sigma Chemical Co. · Jul 1981
THROMBOPLASTIN
K810350 · Pacific Hemostasis · Apr 1981
LANCER COAGENT PT KIT
K792031 · Sherwood Medical Co. · Nov 1979
PROTHROMBIN FREE BEEF PLASMA (PFB)
K791023 · Pacific Hemostasis · Jun 1979
THROMBOPLASTIN DRIED
K780203 · Hyland Therapeutic Div., Travenol Laboratories · Mar 1978