# K091200: Xtract Syringe Keys

- Pathway: 510(k) (Traditional)
- Applicant: Xtract Solutions, LLC
- Decided: Aug 21, 2009 after 119 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: 1 generation back to K883311 (1988). 1 ancestor in all.
1 later device descends from it; 1 cites 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)
- K883311: Count-a-Dose, Pavel Jordan & Associates, Inc. (1988) Summary page 2.

## Most influential descendants
- K112475: Xtract Syringe Key System (2011), 0 descendants of its own

## Indications for use
The XTRACT Solutions Syringe Keys are indicated as accessories for specified commercially available piston hypodermic syringes (for medical purposes) and 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 medications. The XTRACT Solutions Syringe Keys are designed and should be used only with the Terumo SurSaver Mixing Syringes (product code SSQIA2313T) and/or the Greer Optimix (GROM-23) SurSaver Mixing Syringes.

Source page: https://510kreport.com/device/K091200
Methodology: https://510kreport.com/methodology