Cleared Special

K251138 - Promisemed Safety Huber Needles (FDA 510(k) Clearance)

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

K251138 · Promisemed Hangzhou Meditech Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
29d
Days
Class 2
Risk

K251138 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 May 13, 2025 after a review of 29 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 K251138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2025
Decision Date May 13, 2025
Days to Decision 29 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: 128d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 12
Devices cleared under the same product code (PTI) and FDA review panel - the closest regulatory comparables to K251138.
K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing
K252355 · Sb-Kawasumi Laboratories, Inc. · Nov 2025
Promisemed Safety Huber Needles
K243332 · Promisemed Hangzhou Meditech Co., Ltd. · Mar 2025
PowerLoc™ Max Power Injectable Infusion Set
K241353 · Bard Access Systems, Inc. · Nov 2024
Promisemed Safety Huber Needle
K230715 · Promisemed Hangzhou Meditech Co., Ltd. · Jun 2023
Huber Needle Infusion Set, Safety Huber Needle Infusion Set
K200463 · Jiangsu Caina Medical Co.,Ltd · Apr 2021