Cleared Traditional

K230493 - BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube

K230493 is an FDA 510(k) clearance for BD MiniDraw Capillary Blood Collection ..., manufactured by Becton, Dickinson and Company. The device is a Class 2 Hematology device with product code GIM cleared through the Traditional 510(k) pathway after a 277-day FDA review.

K230493 · Becton, Dickinson and Company · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2023
Decision
277d
Days
Class 2
Risk

K230493 is an FDA 510(k) clearance for the BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary .... Classified as Tubes, Vacuum Sample, With Anticoagulant (product code GIM), Class II - Special Controls.

Submitted by Becton, Dickinson and Company (Franklin Lakes, US). The FDA issued a Cleared decision on November 27, 2023 after a review of 277 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Becton, Dickinson and Company devices

FDA 510(k) Submission Details - K230493

510(k) Number K230493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2023
Decision Date November 27, 2023
Days to Decision 277 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
164d slower than avg
Panel avg: 113d · This submission: 277d
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 Hematology 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 K230493.
BD Vacutainer® Citrate Blood Collection Tubes
K240455 · Becton, Dickinson and Company · Oct 2024
BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes
K213670 · Becton, Dickinson and Company · Aug 2023
TransFix/EDTA Vacuum Blood Collection Tubes
K162723 · Caltag Medsystems, Ltd. · Jun 2017
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