Cleared Traditional

K222271 - Verisafe Safety sterile needles

K222271 is the FDA 510(k) clearance for Verisafe Safety sterile needles by Promisemed Hangzhou Meditech Co., Ltd.. It is a Class 2 General Hospital device (product code FMI) cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K222271 · Promisemed Hangzhou Meditech Co., Ltd. · General Hospital
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Feb 2023
Decision
201d
Days
Class 2
Risk

K222271 is an FDA 510(k) clearance for the Verisafe Safety sterile needles. 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 February 15, 2023 after a review of 201 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Promisemed Hangzhou Meditech Co., Ltd. devices

Submission Details

510(k) Number K222271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2022
Decision Date February 15, 2023
Days to Decision 201 days
Submission Type Traditional
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
72d slower than avg
Panel avg: 129d · This submission: 201d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K222271.
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