# K061039: Amsure Disposable Syringe with/Without Needle

- Pathway: 510(k) (Traditional)
- Applicant: Amsino International, Inc.
- Decided: Jun 29, 2006 after 76 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 K944355 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945715: Monoject (R) Piston Syringes; 3,6,12,20,35 and 60CC Sizes, Sherwood Medical Co. (1995) Summary page 1.
- K051574: Nipro Disposable Syringe with or Without Needle, Nipro Medical Corp. (2005)

## Indications for use
The AMSURE® Disposable Syringe with/without Needle is intended for the injection of fluids into, or the withdrawal of fluids from parts of the body below the skin. Needles are intended to mate with male nozzles of piston syringes or administration sets.

Source page: https://510kreport.com/device/K061039
Methodology: https://510kreport.com/methodology