# K073122: Monoject Hypodermic Needle, Model 250, 30 Gauge Hypodermic Needle

- Pathway: 510(k) (Abbreviated)
- Applicant: Covidien Lp, Formerly Registered AS Tyco Healthcar
- Decided: Nov 21, 2007 after 15 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K771203 (1977). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K854547: Monoject Sterile M200 Aluminum/M250 Polypropylene, Sherwood Medical Co. (1986) Summary page 1.
- K012646: Terumo 30 Gauge Hypodermic Needle, Terumo Medical Corp. (2001) Summary page 1.

## Indications for use
These devices are intended for the injection of medications into or the withdrawal of body fluids from parts of the body below the surface of the skin.

Source page: https://510kreport.com/device/K073122
Methodology: https://510kreport.com/methodology