Cleared Traditional

K861449 - VACUUM BLOOD COLLECTING SYSTEM (NEO-TUBE)

K861449 is an FDA 510(k) clearance for VACUUM BLOOD COLLECTING SYSTEM (NEO-TUBE), manufactured by Exel Intl.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K861449

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
Combination Product No
PCCP Authorized No
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.

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 Chemistry 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 K861449.
1400 SERIES EVIDENCE COLLECTION KIT
K896373 · Transidyne General Corp. · Feb 1990
QS90 SMOOTH E ARTERIAL BLOOD SAMPLER
K896514 · Radiometer America, Inc. · Jan 1990
ACCUFIBRIN(TM) BLOOD COLLECTION SYSTEM AF100
K882501 · Terumo Medical Corp. · Jul 1988
J-VAC VACUUM TUBE
K771874 · Jelco Laboratories · Dec 1977
LIQUAEMIB SODIUM PRESERVATIVE, ETC.
K771304 · Organon, Inc. · Aug 1977
LIQUAEMIN SODIUM, HEPARIN SODIUM ETC.
K771305 · Organon, Inc. · Aug 1977