# K080865: FAST1 Intraosseous Infusion System

- Pathway: 510(k) (Traditional)
- Applicant: Pyng Medical Corp.
- Decided: Apr 24, 2008 after 27 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K915409 (1992). 10 ancestors in all.
3 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)
- K072487: FAST1 Intraosseous Infusion System, Pyng Medical Corp. (2008) Summary page 1.
- K052195: EZ-Mio Manual Driver, Vidacare Corporation (2005) Summary page 1.

## Most influential descendants
- K100124: Fastx Sternal Intraosseous Device (2010), 2 descendants of its own
- K130487: Fastresponder Sternal Intraosseous Device (2013), 1 descendant of its own
- K180588: FAST1™ Intraosseous Infusion System; FASTResponder™ Sternal Intraosseous Device (2018), 0 descendants of its own

## Indications for use
The FAST1 TM Intraosseous Infusion System is indicated for use in establishing a sternal intraosseous access route in adult and adolescent patients (12 years of age and older) requiring vascular administration of drugs or fluids to facilitate emergency resuscitation.

Source page: https://510kreport.com/device/K080865
Methodology: https://510kreport.com/methodology