# K122787: Comfort EZ

- Pathway: 510(k) (Traditional)
- Applicant: Simple Diagnostics, Inc.
- Decided: Dec 6, 2012 after 86 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
Longest line of descent: 4 generations back to K941657 (1994). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070917: Feel-Ject Insulin Syringe, Feel Tech (2007) Summary page 1.

## Indications for use
The Comfort EZ disposable sterile Insulin syringes are intended for injection of U100 insulin only. The Comfort EZ disposable sterile Insulin syringes are intended for Injection of U100 Insulin only.

Source page: https://510kreport.com/device/K122787
Methodology: https://510kreport.com/methodology