# K210864: Safety Pen Needle

- Pathway: 510(k) (Traditional)
- Applicant: Sandstone Medical (Suzhou), Inc.
- Decided: Feb 17, 2022 after 331 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 K970737 (1997). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152514: Clickfine AutoProtect Pen Needle, Ypsomed AG (2015) Summary page 4.

## Most influential descendants
- K253622: Safety Pen Needle (2026), 0 descendants of its own

## Indications for use
The safety pen needle is intended for use with pen injector devices for subcutaneous injection of fluids and FDA-approved drugs. HE Model Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection. HS Model Additionally, the product has two safety shields, which lock in place after use (patient end) and upon removal of the needle from the pen (pen connection end). The locked shields help reduce the occurrence of needle sticks from both ends of the needle.

Source page: https://510kreport.com/device/K210864
Methodology: https://510kreport.com/methodology