# K130487: Fastresponder Sternal Intraosseous Device

- Pathway: 510(k) (Traditional)
- Applicant: Pyng Medical Corp.
- Decided: Jun 25, 2013 after 120 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: 6 generations back to K915409 (1992). 12 ancestors in all.
1 later device descends from it; 1 cites 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)
- K100124: Fastx Sternal Intraosseous Device, Pyng Medical Corp. (2010) Summary page 1.
- K080865: FAST1 Intraosseous Infusion System, Pyng Medical Corp. (2008) Summary page 1.

## Most influential descendants
- K180588: FAST1™ Intraosseous Infusion System; FASTResponder™ Sternal Intraosseous Device (2018), 0 descendants of its own

## Indications for use
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 fluids to facilitate emergency resuscitation.

Source page: https://510kreport.com/device/K130487
Methodology: https://510kreport.com/methodology