# K053413: Terumo Syringe for Administration of UV Sensitive Medicines

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Europe N.V.
- Decided: Apr 6, 2006 after 120 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 K771205 (1977). 2 ancestors in all.
36 later devices descend from it; 1 cites it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980181: Terumo Disposable Hypodermc Syringe, Terumo Medical Corp. (1998) Summary page 2.

## Most influential descendants
- K070264: 50 ML Terumo Syringe for Administration of UV Sensitive Medicines, Model BS-50LB (2007), 35 descendants of its own
- K083514: Terumo Syringe with/Without Needle (2009), 34 descendants of its own
- K170651: Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle (2017), 32 descendants of its own
- K192551: 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety Syringe with permanently attached needle (2020), 14 descendants of its own
- K193526: Syringe with safety needle, Safety needle (2020), 7 descendants of its own

## Indications for use
The Terumo Syringe for administration of UV sensitive medicines is a sterile hypodermic syringe for single use, intended for the aspiration of fluids and blood, or for the injection of fluids immediately after filling. The opaque color of the barrel allows the administration of UV sensitive medicines,

Source page: https://510kreport.com/device/K053413
Methodology: https://510kreport.com/methodology