# K193422: Easydrip Pen Needle, Easydrip Plus Pen Needle

- Pathway: 510(k) (Traditional)
- Applicant: Sandstone Medical (Suzhou), Inc.
- Decided: Feb 2, 2021 after 421 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: 7 generations back to K973899 (1997). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161950: Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle, Promisemed Hangzhou Meditech Co., Ltd. (2017) Summary page 4.

## Most influential descendants
- K252908: Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle (2026), 0 descendants of its own

## Indications for use
The Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin.

Source page: https://510kreport.com/device/K193422
Methodology: https://510kreport.com/methodology