# K252908: Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle

- Pathway: 510(k) (Special)
- Applicant: Sandstone Medical (Suzhou), Inc.
- Decided: Mar 25, 2026 after 194 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: 8 generations back to K973899 (1997). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193422: Easydrip Pen Needle, Easydrip Plus Pen Needle, Sandstone Medical (Suzhou), Inc. (2021) Summary page 5.

## Indications for use
The pen needle is intended for use with pen injector devices for subcutaneous injection of fluids and FDA-approved drugs.

Source page: https://510kreport.com/device/K252908
Methodology: https://510kreport.com/methodology