# K023108: Steripack Sterile Disposable Syringe & Sterile Disposable Insulin Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Atlantic Products, Inc.
- Decided: Dec 3, 2002 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Becton Dickinson Syringes: named in the summary without a submission number
- (no number) Exel Intl Syringes: named in the summary without a submission number
- (no number) Nipro Disposable Syringes and Insulin Syringes: named in the summary without a submission number
- (no number) Monoject Piston Syringes: named in the summary without a submission number

## Indications for use
The STERIPACK Sterile Disposable Syringe is intended to be used for injecting fluids into, or for withdrawing fluids from, the body. The STERIPACK Sterile Disposable Insulin Syringe is intended to be used for the subcutaneous injection of insulin.

Source page: https://510kreport.com/device/K023108
Methodology: https://510kreport.com/methodology