# K131661: Infusion Syringe Set

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Medical Manufacturing Co.
- Decided: Nov 5, 2013 after 151 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- 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 K792227 (1979). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063851: Auto-Fill Syringe Kit, Model 7600, Vascular Solutions, Inc. (2007) Summary page 1.
- K792227: Multi-AD Fluid Dispensing System, National Patent Development Corp. (1979) Summary page 1.

## Indications for use
IMMTM Infusion Syringe Set is intended for delivering controlled volume of fluids from reservoirs consistent with the labeled route of administration of fluids by manual operation.

Source page: https://510kreport.com/device/K131661
Methodology: https://510kreport.com/methodology