# K063613: Modification to Terumo Syringe with/Without Needle

- Pathway: 510(k) (Special)
- Applicant: Terumo Medical Corp.
- Decided: Dec 26, 2006 after 21 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: 4 generations back to K771205 (1977). 4 ancestors in all.
36 later devices descend from it; 2 cite it directly.
0 of 41 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 1.
- K052034: Terumo Syringe with/Without Needle, Terumo Medical Corp. (2005) Summary page 1.

## Cited in the summary but kept off the family tree
- K051864: Magstim RAPID2, Magstim Super RAPID2, Models 3004-000, 3005-00, The Magstim Company, Ltd. (2005). Our reading of the summary gave K051864, FDA’s number for Magstim RAPID2, Magstim Super RAPID2, Models 3004-000… (The Magstim Company, Ltd.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Terumo Syringe with/without needle”. Kept off the family tree. 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 Terumo syringe with/without needle is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.

Source page: https://510kreport.com/device/K063613
Methodology: https://510kreport.com/methodology