Cleared Special

K252908 - Easydrip Classic Pen Needle (FDA 510(k) Clearance)

Also includes:
Easydrip Plus Pen Needle Easydrip Classic Pro Pen Needle Easydrip Plus Pro Pen Needle

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K252908 · Sandstone Medical (Suzhou), Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2026
Decision
194d
Days
Class 2
Risk

K252908 is an FDA 510(k) clearance for the Easydrip Classic Pen Needle. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Sandstone Medical (Suzhou), Inc. (Suzhou, CN). The FDA issued a Cleared decision on March 25, 2026 after a review of 194 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Sandstone Medical (Suzhou), Inc. devices

Submission Details

510(k) Number K252908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2025
Decision Date March 25, 2026
Days to Decision 194 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 128d · This submission: 194d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FMI Needle, Hypodermic, Single Lumen

All 688
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