# K102969: Imc Piston Syringes

- Pathway: 510(k) (Special)
- Applicant: International Medsurg Connection
- Decided: Dec 20, 2010 after 75 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: 40 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K022159 (2002). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022159: Piston Syringe & Hypodermic Needle, International Medsurg Connection (2002) Summary page 1.

## Most influential descendants
- K111841: Shifeng Disposable Syringe with or Without Needle (2012), 1 descendant of its own
- K133493: Single Use Sterile Syringe with Needle (2014), 0 descendants of its own

## Recalls of this device
- Dec 15, 2022 · Class II · Z-0939-2023: Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
- Dec 15, 2022 · Class II · Z-0938-2023: Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
- Jun 23, 2017 · Class II · Z-2856-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2839-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2857-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2830-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2851-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2854-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2842-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2862-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2836-201: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2831-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2846-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2844-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2858-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2847-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2828-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2840-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2843-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2853-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2829-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2845-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2834-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2859-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2832-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2850-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2827-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2860-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2837-201: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2848-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2852-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2825-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2861-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2849-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2838-201: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2833-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2826-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2855-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2841-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2835-201: Insufficient documentation to support product sterility claims.

## Indications for use
International Medsurg Connection's piston syringe is intended for the injection of fluids into, or withdraw of fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe consisting of a calibrated hollow barrel and a movable plunger. The intended use is the same as the intended use on INC piston syringe sold by rInternational Medsurg Connection, Reference K022159. '[his submission includes piston syringe that will be sold both sterilc and non-sterile. Non-sterile syringes are to be sold to OEMs for Eta sterilization according to their validated process per ANSI/AMMIIISO 11135. Sterile syringes are to be sold directly to users after £0 sterilization validation per ANSI/AMMI/ISO 11135

Source page: https://510kreport.com/device/K102969
Methodology: https://510kreport.com/methodology