# K192247: Steripath Gen2 Blood Collection System

- Pathway: 510(k) (Traditional)
- Applicant: Magnolia Medical Technologies, Inc.
- Decided: Feb 28, 2020 after 193 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K970259 (1997). 8 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030573: BD Vacutainer Push Button Blood Collection Set, Models 367338, 367344, 367336, 367342, 367335, 367341, Bd Vacutainer Systems Preanalyical Solutions (2003) Summary page 4.

## Most influential descendants
- K200661: Steripath Micro Blood Collection System (2020), 2 descendants of its own
- K231282: LifeOutcomes C-Quest™ Blood Culture Sampling Device (2024), 0 descendants of its own
- 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
- K201237: Velano Vascular Blood Collection Adapter (2022), 0 descendants of its own

## Recalls of this device
- Nov 2, 2021 · Class II · Z-0318-2022: Due to an uptick of complaints associated with premature needle retraction of blood collection system.
- Aug 2, 2021 · Class II · Z-2393-2021: Product was shipped with the incorrect Transfer Adapter Instructions For Use (IFU).

## Indications for use
The Steripath® Gen2 Blood Collection System is a system to draw blood for in vitro diagnostic testing. The Steripath® Gen2 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®). Venipuncture needles are indicated for short term infusion (less than 2 hours).

Source page: https://510kreport.com/device/K192247
Methodology: https://510kreport.com/methodology