Cleared Special

K243332 - Promisemed Safety Huber Needles

K243332 is an FDA 510(k) clearance for Promisemed Safety Huber Needles, manufactured by Promisemed Hangzhou Meditech Co., Ltd.. The device is a Class 2 General Hospital device with product code PTI cleared through the Special 510(k) pathway after a 141-day FDA review.

K243332 · Promisemed Hangzhou Meditech Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2025
Decision
141d
Days
Class 2
Risk

K243332 is an FDA 510(k) clearance for the Promisemed Safety Huber Needles. Classified as Non-coring (huber) Needle (product code PTI), Class II - Special Controls.

Submitted by Promisemed Hangzhou Meditech Co., Ltd. (Hangzhou City, CN). The FDA issued a Cleared decision on March 14, 2025 after a review of 141 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 - K243332

510(k) Number K243332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2024
Decision Date March 14, 2025
Days to Decision 141 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
12d slower than avg
Panel avg: 129d · This submission: 141d
Pathway characteristics
Modification to existing cleared device.

PTI Device Classification - Class 2, Special Controls

Product Code PTI Non-coring (huber) Needle
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
Definition The Non-coring Needle (huber) Is Utilized To Gain Access Into A Subcutaneous Implanted Intravascular Infusion Port But Can Also Be Used To Access Other Non-vascular Implanted Devices With Similar Septums.
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 - PTI Non-coring (huber) Needle

All 13
Devices cleared under the same product code (PTI) and FDA review panel - the closest regulatory comparables to K243332.
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Promisemed Safety Huber Needles
K251138 · Promisemed Hangzhou Meditech Co., Ltd. · May 2025
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K241353 · Bard Access Systems, Inc. · Nov 2024
Promisemed Safety Huber Needle
K230715 · Promisemed Hangzhou Meditech Co., Ltd. · Jun 2023
Intera Refill Kit
K213823 · Intera Oncology, Inc. · Mar 2022
K243332 · Promisemed Safety Huber Needles
Download PDF FDA Summary Promisemed Hangzhou M…