Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle— 510(k) K252908
Substantially EquivalentSandstone Medical (Suzhou), Inc.
FDA 510(k) clearance K252908 for Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle, Substantially Equivalent on 2026-03-25. Applicant: Sandstone Medical (Suzhou), Inc.. Device class: 2.
Summary
Sandstone Medical (Suzhou) has four pen needles in this record: Easydrip Classic, Easydrip Plus, Easydrip Classic Pro and Easydrip Plus Pro. They're filed under FMI, single-lumen hypodermic needles, and the record doesn't give gauges or lengths.
Class II, 21 CFR 880.5570. General Hospital is both the classification panel and the review panel. It was a Special 510(k).
Sandstone Medical (Suzhou) filed from Suzhou, China. The decision came 194 calendar days after receipt (September 12, 2025 to March 25, 2026).
Clearance details
- Applicant
- Sandstone Medical (Suzhou), Inc.
- Product code
- Product code FMI
- Device class
- Class 2
- Regulation
- 21 CFR 880.5570
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Suzhou, CN
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- K260933 — Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)
- K261829 — Profoject Dual-Safety Pen Needles
More clearances from Sandstone Medical (Suzhou), Inc.
view allAdverse events under product code FMI
product code FMI- Death
- 28
- Injury
- 1,517
- Malfunction
- 23,981
- Other
- 18
- Total
- 25,544
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.