Cleared Traditional

K230715 - Promisemed Safety Huber Needle (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K230715 · Promisemed Hangzhou Meditech Co., Ltd. · General Hospital
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Jun 2023
Decision
85d
Days
Class 2
Risk

K230715 is an FDA 510(k) clearance for the Promisemed Safety Huber Needle. 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 June 8, 2023 after a review of 85 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Promisemed Hangzhou Meditech Co., Ltd. devices

Submission Details

510(k) Number K230715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2023
Decision Date June 08, 2023
Days to Decision 85 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
43d faster than avg
Panel avg: 128d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Consultant

Vee Care (Asia) Limited
Wei Shan Hsu

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - PTI Non-coring (huber) Needle

All 12
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