# K112475: Xtract Syringe Key System

- Pathway: 510(k) (Traditional)
- Applicant: Xtract Solutions
- Decided: Nov 10, 2011 after 73 days
- Product code: FMF (Syringe, Piston)
- 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
Longest line of descent: 2 generations back to K883311 (1988). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091200: Xtract Syringe Keys, Xtract Solutions, LLC (2009) Summary page 2.

## Indications for use
The product family of Xtract Solutions Syringe Keys are indicated as accessories provided for specified commercially available piston hypodermic syringes (for medical purposes) which are designed to control the distance the syringe plunger can be drawn through the syringe barrel and to facilitate the user in obtaining accurate, consistent and precise volumetric draws from vials containing liquids such as vaccinations, allergenic extracts and other medications. The Syringe Keys (available for lmL and/or 3 mL hypodermic syringes) are designed as an accessory only for the following syringes: 1 mL syringes: 1 mL Terumo SurSaver Mixing Syringes (SSO1A2313T) and/or 1 mL Greer Optimix (GROM-23) Sur-Saver Mixing Syringes. 3 mL syringes: 3 mL VanishPoint (RTI 10311) Syringes, 23g xl1 3 mL BID SafetyGlidle (80305905) Syringes, 23g x 1V 3 mL BID Integra (BD305271) Syringes 23g x 1" 3 mL BID Precision Glide (80309576) Syringes 20g x 1,, The device assists the user in withdrawing precise and accurate liquid volume withdraws from a vial. The Syringe Keys do not facilitate or assist the user with iniectinci the contents of the hypodermic syringe. The Syringe Keys can be used by medical personnel as well as individuals who are not medical professionals; but, have been instructed in their use. Syringe Keys will be available for specified piston hypodermic syringe models manufactured by designated syringe manufacturers.

Source page: https://510kreport.com/device/K112475
Methodology: https://510kreport.com/methodology