# K222299: Steripath Micro Blood Collection System

- Pathway: 510(k) (Traditional)
- Applicant: Magnolia Medical Technologies
- Decided: Nov 30, 2022 after 121 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K970259 (1997). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200661: Steripath Micro Blood Collection System, Magnolia Medical Technologies, Inc. (2020) Summary page 4.

## Indications for use
The Steripath® Micro Blood Collection System is a system to draw blood for in vitro diagnostic testing. The Steripath® Micro Blood Collection System is indicated for use as a blood collection system that diverts and sequesters the initial specimen prior to collection of a subsequent test sample to reduce the frequency of blood culture contamination when contaminants are present in the initial blood sample compared to blood cultures drawn with standard procedure without manual diversion. Additionally, components of the system may be used for infusion following sample collection after disconnection of the Initial Specimen Diversion Device® (ISDD®).

Source page: https://510kreport.com/device/K222299
Methodology: https://510kreport.com/methodology