Cleared Special

K243806 - Safety Winged Blood Collection Sets

K243806 is the FDA 510(k) clearance for Safety Winged Blood Collection Sets by Promisemed Hangzhou Meditech Co., Ltd.. It is a Class 2 General Hospital device (product code FMI) cleared through the Special 510(k) pathway after a 30-day FDA review.

K243806 · Promisemed Hangzhou Meditech Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
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Jan 2025
Decision
30d
Days
Class 2
Risk

K243806 is an FDA 510(k) clearance for the Safety Winged Blood Collection Sets. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Promisemed Hangzhou Meditech Co., Ltd. (Hangzhou City, CN). The FDA issued a Cleared decision on January 10, 2025 after a review of 30 days - a notably fast clearance 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Promisemed Hangzhou Meditech Co., Ltd. devices

Submission Details

510(k) Number K243806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2024
Decision Date January 10, 2025
Days to Decision 30 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
99d faster than avg
Panel avg: 129d · This submission: 30d
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 235
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