# K112512: Vanishpoint Blood Collection Set

- Pathway: 510(k) (Traditional)
- Applicant: Retractable Technologies, Inc.
- Decided: Oct 20, 2011 after 51 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K970259 (1997). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
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.

## Most influential descendants
- K122355: Vanishpoint Blood Collection Set (2013), 0 descendants of its own

## Indications for use
The intended use Of the Vanishiloint® Blood Collection Set is to provide safe and reliable access to the vascular systemn to obtain blood specimens fromn patients. 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/K112512
Methodology: https://510kreport.com/methodology