# K160199: Advocate Insulin Pen Needles

- Pathway: 510(k) (Traditional)
- Applicant: Diabetic Supply of Suncoast, Inc.
- Decided: Oct 19, 2016 after 265 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: 4 generations back to K973899 (1997). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121632: Comfort EZ, Simple Diagnostics, Inc. (2012) Summary page 4.

## Indications for use
These disposable sterile insulin pen needles are intended for subcutaneous injection of insulin in the treatment of diabetes.

Source page: https://510kreport.com/device/K160199
Methodology: https://510kreport.com/methodology