Cleared Special

K211634 - Hypodermic Needle-Pro EDGE Safety Device

K211634 is an FDA 510(k) clearance for Hypodermic Needle-Pro EDGE Safety Device, manufactured by Smiths Medical Asd, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Special 510(k) pathway after a 91-day FDA review.

K211634 · Smiths Medical Asd, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2021
Decision
91d
Days
Class 2
Risk

K211634 is an FDA 510(k) clearance for the Hypodermic Needle-Pro EDGE Safety Device. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Smiths Medical Asd, Inc. (Plymouth, US). The FDA issued a Cleared decision on August 26, 2021 after a review of 91 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K211634

510(k) Number K211634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2021
Decision Date August 26, 2021
Days to Decision 91 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
38d faster than avg
Panel avg: 129d · This submission: 91d
Pathway characteristics
Modification to existing cleared device.

FMI Device Classification - Class 2, Special Controls

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 694
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K211634 · Hypodermic Needle-Pro EDGE Safety Device
Download PDF FDA Summary Smiths Medical Asd, I…