# K093972: BD Microtainer Map Microtube for Automated Process, Model 363706

- Pathway: 510(k) (Special)
- Applicant: Becton, Dickinson & CO
- Decided: Jan 21, 2010 after 28 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K940905 (1994). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940905: Microtainer Brand Tube with Edta (K2), Bd Becton Dickinson Vacutainer Systems Preanalytic (1994) Summary page 3.

## Most influential descendants
- K230493: BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube (2023), 0 descendants of its own
- K182078: MiniCollect K2E K2EDTA Tubes (2019), 0 descendants of its own

## Recalls of this device
- Feb 11, 2011 · Not classified · Z-0176-2012: BD Microtainer MAP Microtube is being recalled due to the potential clotting of blood specimens resulting from a reduced amount of EDTA additive.

## Indications for use
BD Microtainer MAP Microtube for Automated Process with K2EDTA is used to collect, anticoagulate, transport and store skin puncture blood specimens for measurement of the following hematological parameters: White Blood Cells (WBC), Red Blood Cells (RBC), Hemoglobin (HgB), Hematocrit (HCT), Mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), Mean corpuscular hemoglobin concentration (MCHC), Platelets, 5-part White Blood Cell (WBC) differentials (Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils), Reticulocytes and Whole Blood Lead testing.

Source page: https://510kreport.com/device/K093972
Methodology: https://510kreport.com/methodology