# K092986: Acacia Piston Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Acacia, Inc.
- Decided: Oct 27, 2009 after 29 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K771205 (1977). 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)
- K951871: Piston Syringe, Baxa Corp. (1995) Summary page 1.
- K872820: Safety Syringe, Bd Becton Dickinson Vacutainer Systems Preanalytic (1987) Summary page 1.
- K811065: Piston Syringe, Sherwood Medical Co. (1981). Our reading of the summary gave K811965, FDA’s number for Visitec Needle Range (Gasterurology) (Visitec Co.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Sherwood Medical Piston Syringe”.
- K771205: Hypodermic Syringe, Terumo America, Inc. (1977) Summary page 1.

## Recalls of this device
- Feb 13, 2015 · Class II · Z-1262-2015: The firm is recalling sterile enteral feeding syringes due to determining that the sterility of the affected products may be compromised as a result of a potential breach in packaging.

## Indications for use
The Acacia Piston Syringe is indicated for the injection of fluids into, or withdrawal fluids from, the body. It is also used as a dispenser, a measuring device, and a fluid transfer device.

Source page: https://510kreport.com/device/K092986
Methodology: https://510kreport.com/methodology