# K972969: Quick-Draw Capillary Whole Blood Collection System

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Medical Technologies, Inc.
- Decided: Sep 22, 1997 after 42 days
- Product code: GIO (Tube, Collection, Capillary Blood)
- Device class: 1
- Regulation: 21 CFR 864.6150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The Quick-Draw Capillary Whole Blood Collection System is intended for in vitro diagnostic use to facilitate the collection of whole blood specimens from a capillary puncture site, i.e., finger or heel stick. The system is composed of the Quick-Draw collector with a collection tube attached. The Quick-Draw collector is attached to the Quick-Draw Handle, a battery operated vacuum device. When assembled and activated, the system aspirates blood specimens from the puncture site into the collection tube.

Source page: https://510kreport.com/device/K972969
Methodology: https://510kreport.com/methodology