# K122355: Vanishpoint Blood Collection Set

- Pathway: 510(k) (Traditional)
- Applicant: Retractable Technologies, Inc.
- Decided: Aug 23, 2013 after 385 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: 6 generations back to K970259 (1997). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030573: BD Vacutainer Push Button Blood Collection Set, Models 367338, 367344, 367336, 367342, 367335, 367341, Bd Vacutainer Systems Preanalyical Solutions (2003) Summary page 1.
- K112512: Vanishpoint Blood Collection Set, Retractable Technologies, Inc. (2011) Summary page 1.

## Indications for use
The intended use of the VanishPoint Blood Collection Set is to provide safe and reliable access to the vascular system to obtain blood specimens from patients. The VanishPoint Blood Collection Set is also indicated for intermittent or short-term intravenous administration of fluid (up to 2 hours). It may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure. The VanishPoint Blood Collection Set aids in the prevention of needlestick injuries.

Source page: https://510kreport.com/device/K122355
Methodology: https://510kreport.com/methodology