# Sandstone Medical (Suzhou), Inc.

- Location (FDA's records): Suzhou, CN
- FDA decisions: 3 (2021–2026): 3 510(k) clearances
- Product codes: FMI (3)
- 510(k) review time since 2016: median 331 days, against 143 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 2 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ypsomed AG: 1 (https://510kreport.com/company/ypsomed)
- Promisemed Hangzhou Meditech Co., Ltd.: 1 (https://510kreport.com/company/promisemed-hangzhou-meditech)

## Firms that cite its devices most
- Ningbo Medsun Medical Co., Ltd.: 1 (https://510kreport.com/company/ningbo-medsun-medical)

## Its most-cited devices
- K210864: Safety Pen Needle (2022), cited by 1
- K193422: Easydrip Pen Needle, Easydrip Plus Pen Needle (2021), cited by 1

## Recent decisions
- K252908: Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle (Mar 25, 2026)
- K210864: Safety Pen Needle (Feb 17, 2022)
- K193422: Easydrip Pen Needle, Easydrip Plus Pen Needle (Feb 2, 2021)

Source page: https://510kreport.com/company/sandstone-medical-suzhou