# K070264: 50 ML Terumo Syringe for Administration of UV Sensitive Medicines, Model BS-50LB

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Europe N.V.
- Decided: May 29, 2007 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: 3 generations back to K771205 (1977). 4 ancestors in all.
35 later devices descend from it; 1 cites it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053413: Terumo Syringe for Administration of UV Sensitive Medicines, Terumo Europe N.V. (2006) Summary page 1.
- K980987: Becton Dickinson Syringe, Bd Becton Dickinson Vacutainer Systems Preanalytic (1998) Summary page 1.

## Most influential descendants
- 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
- K210443: PLPT LDV (Low Dead Volume) Sterile Syringe (2021), 6 descendants of its own

## Indications for use
The 50 ml Terumo Syringes for administration of UV sensitive medicines are sterile hypodermic syringes for single use, intended for the aspiration of fluids and blood, or for the injection of fluids immediately after filling. Intended for manual use or for use with power driven syringe pumps. The opaque color of the barrel allows the administration of UV sensitive medicines.

Source page: https://510kreport.com/device/K070264
Methodology: https://510kreport.com/methodology