Cleared Traditional

K810350 - THROMBOPLASTIN

K810350 is an FDA 510(k) clearance for THROMBOPLASTIN, manufactured by Pacific Hemostasis. The device is a Class 2 Immunology device with product code GJS cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K810350 · Pacific Hemostasis · Immunology device
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Apr 1981
Decision
63d
Days
Class 2
Risk

K810350 is an FDA 510(k) clearance for the THROMBOPLASTIN. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by Pacific Hemostasis (Walker, US). The FDA issued a Cleared decision on April 14, 1981 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 864.7750 - the FDA immunology 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 - K810350

510(k) Number K810350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1981
Decision Date April 14, 1981
Days to Decision 63 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 105d · This submission: 63d
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 Immunology 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 K810350.
EASYTOUCH TROMBOPLASTIN REAGENT
K832427 · Worthington Diagnostic Systems · Oct 1983
LIQUID THROMBOPLASTIN REAGENT
K830331 · Helena Laboratories · Apr 1983
SIGMA PROCEDURE #890
K811784 · Sigma Chemical Co. · Jul 1981
LANCER COAGENT PT KIT
K792031 · Sherwood Medical Co. · Nov 1979
PROTHROMBIN REFERENCE PLASMA (HUMAN)
K791022 · Pacific Hemostasis · Jul 1979
PROTHROMBIN FREE BEEF PLASMA (PFB)
K791023 · Pacific Hemostasis · Jun 1979