# K945952: Vacutainer (R) Brand Plus PST (TM) Plasma Separation Tube

- Pathway: 510(k) (Traditional)
- Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decided: Jan 18, 1995 after 43 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
18 later devices descend from it; 3 cite it directly.
0 of 19 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
- K972075: Vacutainer Brand PPT Plasma Preparation Tube (1998), 13 descendants of its own
- K110701: Oragene-DX Ogd-500; Oragene-DX Ogd-575; Oragene-DX Oxd-525; Oragene-DX Oyd-500 (2011), 6 descendants of its own
- K141410: Oragene DX Ogd-500.001 (2015), 3 descendants of its own
- K152556: Oragene Dx (2016), 2 descendants of its own
- K022130: BD Vacutainer Plus PST II Tube (2002), 2 descendants of its own

## Recalls of this device
- Jun 12, 2019 · Class II · Z-2300-2019: 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-2304-2019: 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-2301-2019: 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-2305-2019: 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-2302-2019: 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-2303-2019: 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-2308-2019: 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.
- Mar 16, 2017 · Class II · Z-1746-2017: BD is initiating this product correction of multiple lots of BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (13x75 mm x 4.5 mL). A limited number of tubes in these lots may exhibit
- Jan 16, 2017 · Class II · Z-1189-2017: A portion of this lot of blood collection tubes was manufactured with approximately twice the expected amount of buffered sodium citrate additive, an anticoagulant.
- Mar 5, 2012 · Class III · Z-0911-2013: BD is conducting a recall of the BD Vacutainer Plus Plastic Plasma Separator Tube (PST) with Light Green/BD Homogard Closure due to a deformed top of the tube reservoir reported in two customer compla

Source page: https://510kreport.com/device/K945952
Methodology: https://510kreport.com/methodology