# K970803: Anti-Stick Syringe with Integral Hypodermic Needle Vanishpoint Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Retractable Technologies, Inc.
- Decided: May 29, 1997 after 86 days
- Product code: MEG (Syringe, Antistick)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K113587: Automatically Retractable Safety Syringe (with Fixed Needle) (2012), 3 descendants of its own
- K141640: Automatically Retractable Safety Syringes with Fixed Needle (2014), 1 descendant of its own
- K222452: Disposable Automatically Retractable Safety Syringes (with detachable needle) (2022), 0 descendants of its own
- K141349: Disposable sterile needle retractable safety syringe (2015), 0 descendants of its own
- K133635: Easypoint Needle (2014), 0 descendants of its own

## Indications for use
The function of the VanishPoint™ Syringe is to provide a safe and reliable method of injecting medication into a patient or withdrawing blood from a patient. The VanishPoint™ Syringe works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user. Because the contaminated needle is automatically withdrawn into the syringe barrel, the syringe user is protected from accidental needlesticks. These accidental needlesticks would occur between removing the needle from the patient and disposing of the syringe in a sharps disposable container.

Source page: https://510kreport.com/device/K970803
Methodology: https://510kreport.com/methodology
