Cleared Traditional

K771305 - LIQUAEMIN SODIUM, HEPARIN SODIUM ETC.

K771305 is an FDA 510(k) clearance for LIQUAEMIN SODIUM, manufactured by Organon, Inc.. The device is a Class 2 Hematology device with product code GIM cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K771305 · Organon, Inc. · Hematology device
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Aug 1977
Decision
21d
Days
Class 2
Risk

K771305 is an FDA 510(k) clearance for the LIQUAEMIN SODIUM, HEPARIN SODIUM ETC.. Classified as Tubes, Vacuum Sample, With Anticoagulant (product code GIM), Class II - Special Controls.

Submitted by Organon, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 4, 1977 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1675 - 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 Organon, Inc. devices

FDA 510(k) Submission Details - K771305

510(k) Number K771305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1977
Decision Date August 04, 1977
Days to Decision 21 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
92d faster than avg
Panel avg: 113d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GIM Device Classification - Class 2, Special Controls

Product Code GIM Tubes, Vacuum Sample, With Anticoagulant
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1675
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 - GIM Tubes, Vacuum Sample, With Anticoagulant

All 29
Devices cleared under the same product code (GIM) and FDA review panel - the closest regulatory comparables to K771305.
VACUUM BLOOD COLLECTING SYSTEM (NEO-TUBE)
K861449 · Exel Intl. · Sep 1986
J-VAC VACUUM TUBE
K771874 · Jelco Laboratories · Dec 1977
LIQUAEMIB SODIUM PRESERVATIVE, ETC.
K771304 · Organon, Inc. · Aug 1977
BLOOD COLLECTION TUBE, GRAY
K771053 · Sherwood Medical Industries · Jun 1977
BLOOD COLLECTION TUBE, BLUE
K771054 · Sherwood Medical Industries · Jun 1977
BLOOD COLLECTION TUBE, RED
K771055 · Sherwood Medical Industries · Jun 1977