# K083514: Terumo Syringe with/Without Needle

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Europe N.V.
- Decided: May 22, 2009 after 177 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: 5 generations back to K771205 (1977). 8 ancestors in all.
34 later devices descend from it; 2 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023271: Terumo Syringe with/Without Needle, Terumo Medical Corp. (2002) Summary page 2.
- K052034: Terumo Syringe with/Without Needle, Terumo Medical Corp. (2005) Summary page 2.
- K063613: Modification to Terumo Syringe with/Without Needle, Terumo Medical Corp. (2006) Summary page 2.
- K070264: 50 ML Terumo Syringe for Administration of UV Sensitive Medicines, Model BS-50LB, Terumo Europe N.V. (2007) Summary page 2.

## Most influential descendants
- 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
- K221247: Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle (2022), 3 descendants of its own

## Indications for use
The Teruno Syringe with/without needle 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.

Source page: https://510kreport.com/device/K083514
Methodology: https://510kreport.com/methodology