Cleared Traditional

K162723 - TransFix/EDTA Vacuum Blood Collection Tubes

K162723 is an FDA 510(k) clearance for TransFix/EDTA Vacuum Blood Collection Tubes, manufactured by Caltag Medsystems, Ltd.. The device is a Class 2 Immunology device with product code GIM cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K162723 · Caltag Medsystems, Ltd. · Immunology device
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Jun 2017
Decision
266d
Days
Class 2
Risk

K162723 is an FDA 510(k) clearance for the TransFix/EDTA Vacuum Blood Collection Tubes. Classified as Tubes, Vacuum Sample, With Anticoagulant (product code GIM), Class II - Special Controls.

Submitted by Caltag Medsystems, Ltd. (Buckingham, GB). The FDA issued a Cleared decision on June 22, 2017 after a review of 266 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1675 - the FDA immunology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Caltag Medsystems, Ltd. devices

FDA 510(k) Submission Details - K162723

510(k) Number K162723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2016
Decision Date June 22, 2017
Days to Decision 266 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
161d slower than avg
Panel avg: 105d · This submission: 266d
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 Immunology 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 K162723.
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
CYTO-CHEX BCT
K080552 · Streck · Jul 2008
VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE)
K971449 · Becton Dickinson Vacutainer Systems · Jun 1997
GREINER VACUETTE BLOOD COLLECTION TUBE
K971221 · Greiner America, Inc. · May 1997