# K970380: F.a.S.T. 1 Intraosseous Infusion System

- Pathway: 510(k) (Traditional)
- Applicant: Pyng Medical Corp.
- Decided: Apr 25, 1997 after 81 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: 1 generation back to K883014 (1988). 3 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913258: Disposable Introsseous Infusion Needles, Cook, Inc. (1992) Summary page 1.
- K915409: Intraosseous Access Needle, Cook, Inc. (1992) Summary page 1.
- K883014: Modified Intended Use of Monoject Bone Marrow Need, Sherwood Medical Co. (1988) Summary page 1.

## Most influential descendants
- K072487: FAST1 Intraosseous Infusion System (2008), 4 descendants of its own
- 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
- K063567: EZ-Mio Sternal (2007), 1 descendant of its own

## Indications for use
The F.A.S.T. 1™ Intraosseous Infusion System is intended for intraosseous infusion as an alternative to intravenous access to facilitate emergency resuscitation through the use of drugs and fluids.

Source page: https://510kreport.com/device/K970380
Methodology: https://510kreport.com/methodology