# K200661: Steripath Micro Blood Collection System

- Pathway: 510(k) (Special)
- Applicant: Magnolia Medical Technologies, Inc.
- Decided: Oct 8, 2020 after 210 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K970259 (1997). 9 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192247: Steripath Gen2 Blood Collection System, Magnolia Medical Technologies, Inc. (2020) Summary page 4.

## Most influential descendants
- K220677: Kurin Blood Culture Collection Set with Kurin Lock Technology (2023), 0 descendants of its own
- K222299: Steripath Micro Blood Collection System (2022), 0 descendants of its own

## 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/K200661
Methodology: https://510kreport.com/methodology