# K953940: Terumo Retractable Needle (RN) Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corp.
- Decided: May 21, 1996 after 274 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: 1 generation back to K771205 (1977). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K771205: Hypodermic Syringe, Terumo America, Inc. (1977) Summary page 1.
- K771203: Disp. Hypodermic Needle, Terumo America, Inc. (1977) Summary page 1.
- K925039: Safesnap Safety Syringe, U.S. Medical Instruments, Inc. (1994) Summary page 1.

## Indications for use
The intended use of the Terumo Medical Corporation (Terumo) RN Syringe is to inject fluids into, or withdraw fluids from, the body below the surface of the skin for medical purposes.

Source page: https://510kreport.com/device/K953940
Methodology: https://510kreport.com/methodology