# K944566: Vacutainer Brand Plus Sodium Heparin Tube

- Pathway: 510(k) (Traditional)
- Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decided: Nov 10, 1994 after 50 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.
3 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K960857: Greiner Vacuette Blood Collection Tube W/Lithium Heparin & Gel Separator (1996), 1 descendant of its own
- K252040: BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes (2026), 0 descendants of its own
- K011699: Vacuette Evacuated Blood Collection Tubes (2001), 0 descendants of its own

## Recalls of this device
- Jun 12, 2019 · Class II · Z-2306-2019: False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.
- Jun 12, 2019 · Class II · Z-2307-2019: False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.

Source page: https://510kreport.com/device/K944566
Methodology: https://510kreport.com/methodology