Cleared Traditional

LIQUAEMIN SODIUM, HEPARIN SODIUM ETC. (K771305) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

Device Classification

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 38
Devices cleared under the same product code (GIM) and FDA review panel - the closest regulatory comparables to K771305.
BD Vacutainer® Citrate Blood Collection Tubes
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VACUTAINER BRAND SAFETY-GARD PHLEBOTOMY SYSTEM
K945458 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1995
CORVAC PLASTIC BLOOD COLLECTION TUBE
K944814 · Sherwood Medical Co. · Dec 1994
MONOJECT BLOOD COLLECTION TUBES W/SAFETY STOPPER
K940058 · Sherwood Medical Co. · May 1994