# K940905: Microtainer Brand Tube with Edta (K2)

- Pathway: 510(k) (Traditional)
- Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decided: Aug 2, 1994 after 159 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 4 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K093972: BD Microtainer Map Microtube for Automated Process, Model 363706 (2010), 2 descendants of its own
- 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
- K063357: Minicollect Capillary Blood Collection Tubes (2007), 0 descendants of its own
- K982999: Greiner Minicollect Edta Blood Collection Tube (1998), 0 descendants of its own

## Recalls of this device
- Aug 20, 2004 · Not classified · Z-1603-05: "Please be aware that this is not a new recall. This recall was initially classified in 2005 (Z-0052-05). The firm has taken action; but, due to administrative issues additional products are now being
- Oct 16, 2002 · Not classified · Z-0447-03: Insufficient amount of EDTA found within the tube causing clotting and erroneous platelet counts.

Source page: https://510kreport.com/device/K940905
Methodology: https://510kreport.com/methodology