Cleared Traditional

K861449 - VACUUM BLOOD COLLECTING SYSTEM (NEO-TUBE)

K861449 is the FDA 510(k) clearance for VACUUM BLOOD COLLECTING SYSTEM (NEO-TUBE) by Exel Intl.. It is a Class 2 Chemistry device (product code GIM) cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K861449 · Exel Intl. · Chemistry device
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Sep 1986
Decision
152d
Days
Class 2
Risk

K861449 is an FDA 510(k) clearance for the VACUUM BLOOD COLLECTING SYSTEM (NEO-TUBE). Classified as Tubes, Vacuum Sample, With Anticoagulant (product code GIM), Class II - Special Controls.

Submitted by Exel Intl. (Fort Lauderdale, US). The FDA issued a Cleared decision on September 16, 1986 after a review of 152 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1675 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Exel Intl. devices

Submission Details

510(k) Number K861449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1986
Decision Date September 16, 1986
Days to Decision 152 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 88d · This submission: 152d
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 Chemistry devices follow this clearance model.

Regulatory Peers - GIM Tubes, Vacuum Sample, With Anticoagulant

All 22
Devices cleared under the same product code (GIM) and FDA review panel - the closest regulatory comparables to K861449.
CORVAC BLOOD COLLECTION TUBE
K915213 · Sherwood Medical Co. · Jan 1992
QS90 SMOOTH E ARTERIAL BLOOD SAMPLER
K896514 · Radiometer America, Inc. · Jan 1990
ACCUFIBRIN(TM) BLOOD COLLECTION SYSTEM AF100
K882501 · Terumo Medical Corp. · Jul 1988
LIQUAEMIB SODIUM PRESERVATIVE, ETC.
K771304 · Organon, Inc. · Aug 1977
LIQUAEMIN SODIUM, HEPARIN SODIUM ETC.
K771305 · Organon, Inc. · Aug 1977
BLOOD COLLECTION TUBE, GRAY
K771053 · Sherwood Medical Industries · Jun 1977