# K070856: Icu Medical Single-Use Syringe

- Pathway: 510(k) (Abbreviated)
- Applicant: Icu Medical, Inc.
- Decided: Oct 5, 2007 after 191 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 K980580 (1998). 2 ancestors in all.
18 later devices descend from it; 2 cite it directly.
2 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024052: Merit Medical 1-ML Syringe, Merit Medical Systems, Inc. (2003) Summary page 1.

## Most influential descendants
- K081361: Chemoclave Cytotoxic Medication Preparation and Delivery System, Model, CH-XXXX (2008), 12 descendants of its own
- K131549: Chemolock, Chemolock Port (2013), 10 descendants of its own
- K141448: Tevadaptor Closed Drug Reconstitution and Transfer System (2015), 9 descendants of its own
- K103736: DMC Medical Single-Use Polycarbonate Syringe (2011), 4 descendants of its own
- K192866: Chemfort CSTD (2020), 3 descendants of its own

## Indications for use
ICU Medical piston syringes are single use syringes that are intended for injecting fluids into or withdrawing fluids from the body.

Source page: https://510kreport.com/device/K070856
Methodology: https://510kreport.com/methodology