# K982922: Vacutainer Brand Blood Collection Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Vacutainer Systems
- Decided: Sep 22, 1998 after 34 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K875117 (1988). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K896514: QS90 Smooth E Arterial Blood Sampler, Radiometer America, Inc. (1990) Summary page 4.
- K875117: Ciba Corning Balanced Heparin for CA++, Ciba Corning Diagnostics Corp. (1988) Summary page 4.
- (no number) Becton Dickinson Division Arterial Blood Gas Syringe: named in the summary without a submission number

## Most influential descendants
- K022426: BD Preset Blood Collection Syringe, BD a-Line Blood Collection Syringe, Models 365313, 365323,365316,365356,365373,36538 (2002), 2 descendants of its own
- K260128: BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes (2026), 0 descendants of its own
- K202446: BD Preset Syringe & BD A-Line Syringe (2020), 0 descendants of its own

## Indications for use
The VACUTAINER Brand Blood Collection Syringe is intended to collect whole blood specimens for diagnostic testing which may include: pH, blood gases, electrolytes (including ionized calcium and magnesium), metabolytes, co-oximetry, and other tests.

Source page: https://510kreport.com/device/K982922
Methodology: https://510kreport.com/methodology