# K072487: FAST1 Intraosseous Infusion System

- Pathway: 510(k) (Special)
- Applicant: Pyng Medical Corp.
- Decided: Feb 13, 2008 after 162 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: 2 generations back to K883014 (1988). 4 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970380: F.a.S.T. 1 Intraosseous Infusion System, Pyng Medical Corp. (1997) Summary page 1.

## Most influential descendants
- K080865: FAST1 Intraosseous Infusion System (2008), 3 descendants of its own
- 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 Intraosseous Infusion System is indicated for use in establishing a sternal intraosseous access route in adult patients requiring vascular administration of drugs or fluids to facilitate emergency resuscitation.

Source page: https://510kreport.com/device/K072487
Methodology: https://510kreport.com/methodology