Cleared Traditional

VACUUM BLOOD COLLECTING SYSTEM (NEO-TUBE) (K861449) - FDA 510(k) Clearance

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

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 38
Devices cleared under the same product code (GIM) and FDA review panel - the closest regulatory comparables to K861449.
BD Vacutainer® Citrate Blood Collection Tubes
K240455 · Becton, Dickinson and Company · Oct 2024
BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube
K230493 · Becton, Dickinson and Company · Nov 2023
BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes
K213670 · Becton, Dickinson and Company · Aug 2023
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