Cleared Traditional

K232165 - Sterile Safety Hypodermic Needles for S...

Also marketed or referenced as:
Sterile Hypodermic Needles for Single Use- Disposable Needles Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles

K232165 is an FDA 510(k) clearance for Sterile Safety Hypodermic Needles for S..., manufactured by Berpu Medical Technology Co., Ltd.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K232165 · Berpu Medical Technology Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2024
Decision
195d
Days
Class 2
Risk

K232165 is an FDA 510(k) clearance for the Sterile Safety Hypodermic Needles for Single Use. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Berpu Medical Technology Co., Ltd. (Wenzhou, CN). The FDA issued a Cleared decision on February 1, 2024 after a review of 195 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 Berpu Medical Technology Co., Ltd. devices

FDA 510(k) Submission Details - K232165

510(k) Number K232165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2023
Decision Date February 01, 2024
Days to Decision 195 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
66d slower than avg
Panel avg: 129d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

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 Consultant

Mid-Link Consulting Co, Ltd.
Diana Hong

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 - FMI Needle, Hypodermic, Single Lumen

All 271
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K232165.
ACE Cannula
K242741 · Ace Medical Industry Co., Ltd. · Jan 2025
Verifine® Pen Needles
K242632 · Promisemed Hangzhou Meditech Co., Ltd. · Sep 2024
ZIEN IO Intraosseous Access System
K240915 · Zien Medical Technologies, Inc. · Jul 2024
Sterile Hypodermic Needles for Single Use
K233037 · Zhejiang Kindly Medical Device Co., Ltd. · Dec 2023
SteriCap Safety Needle
K233343 · Ocuject, LLC · Nov 2023
MESORAM® Hypodermic Needle (710301)
K230070 · Promamedical, Inc. · Oct 2023