# K971763: Blood Collection Tube Holder Vanishpoint Tube Holder/Small Tube Adapter

- Pathway: 510(k) (Traditional)
- Applicant: Retractable Technologies, Inc.
- Decided: Aug 26, 1997 after 105 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K082511: Medigard Blood Collection Device (2009), 0 descendants of its own
- K041941: Safe T Retractable Blood Collection Device (2004), 0 descendants of its own

## Indications for use
The function of the VanishPoint® Tube Holder is to provide a safe and reliable method for facilitating blood withdrawal from a patient into evacuated blood collection tubes without exposing the phlebotomist to an accidental needlestick injury. The VanishPoint® Tube Holder works like a conventional tube holder except for its ability to retract the contaminated needle inside of the tube holder immediately after blood collection. Regular size collection tubes are inserted into the tube holder to collect blood through the blood collection needle. Regular size collection tubes are 13mm and 16mm diameter. After the last evacuated tube is filled, the tube is removed and the tube holder endcap is pressed onto the back-end of the tube holder. The needle retraction mechanism is automatically activated and the contaminated needle is withdrawn from the patient’s vein and carried into the tube holder. The tube holder cannot be reused. This automatic needle retraction protects the phlebotomist from an accidental needlestick. Accidental needlesticks typically occur between removing the needle from the patient, removing the needle from a reusable tube holder and disposing of the needle into a sharps disposal container. The function of the VanishPoint®Small Tube Adapter is to permit the phlebotomist to use the VanishPoint® Tube Holder with small volume blood collection tubes. Small volume collection tubes are 10.25mm in diameter. The tube adapter is inserted into the tube holder and the small collection tube is inserted into the tube adapter. After the evacuated tube is filled with blood, the tube adapter is removed from the tube holder and the tube is removed from the tube adapter. The tube adapter can be reused.

Source page: https://510kreport.com/device/K971763
Methodology: https://510kreport.com/methodology