# K153599: Concert Medical Hands-Free Syringe (HFS)

- Pathway: 510(k) (Traditional)
- Applicant: Concert Medical, LLC
- Decided: Sep 1, 2016 after 260 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K800560 (1980). 7 ancestors in all.
1 later device descends 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)
- K980738: Psi-Tec Syringe Infusion Pump and Accessories for General Fluid Irrigaion/Infiltration, Byron Medical (1998) Summary page 4.

## Most influential descendants
- K230083: Safira (2023), 0 descendants of its own

## Indications for use
The Concert Medical Hands-Free Syringe (HFS) is indicated for general fluid irrigation/infiltration.

Source page: https://510kreport.com/device/K153599
Methodology: https://510kreport.com/methodology