# K033373: Monoject Insulin Syringe

- Pathway: 510(k) (Special)
- Applicant: Tyco Healthcare
- Decided: Nov 13, 2003 after 22 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- 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: 2 generations back to K851090 (1985). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024112: BD Insulin Syringe, Becton, Dickinson & CO (2003)
- K991758: Monoject Insulin Syringe, The Kendal Co. (1999) Summary page 1.

## Recalls of this device
- Oct 9, 2008 · Not classified · Z-0284-2009: Mislabeled: Package labeled as an insulin syringe for use with U-100 insulin contains an insulin syringe for use with U-40 insulin. Risk of overdose of insulin.

## Indications for use
Kendall Monoject Insulin Syringes are intended for subcutaneous injection of U-100 insulin.

Source page: https://510kreport.com/device/K033373
Methodology: https://510kreport.com/methodology