# K180588: FAST1™ Intraosseous Infusion System; FASTResponder™ Sternal Intraosseous Device

- Pathway: 510(k) (Traditional)
- Applicant: Teleflex Medical
- Decided: Apr 17, 2018 after 42 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: 7 generations back to K915409 (1992). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080865: FAST1 Intraosseous Infusion System, Pyng Medical Corp. (2008) Summary page 4.
- K130487: Fastresponder Sternal Intraosseous Device, Pyng Medical Corp. (2013) Summary page 4.

## Indications for use
The FAST1™ 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. The FASTResponder™ Sternal Intraosseous Device 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 fluid to facilitate emergency resuscitation.

Source page: https://510kreport.com/device/K180588
Methodology: https://510kreport.com/methodology