Cleared Traditional

K212514 - Safety Pen Needle for Single Use

K212514 is an FDA 510(k) clearance for Safety Pen Needle for Single Use, 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 262-day FDA review.

K212514 · Berpu Medical Technology Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2022
Decision
262d
Days
Class 2
Risk

K212514 is an FDA 510(k) clearance for the Safety Pen Needle for Single Use, Insulin Pen Needles. 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 April 29, 2022 after a review of 262 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 - K212514

510(k) Number K212514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2021
Decision Date April 29, 2022
Days to Decision 262 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
133d slower than avg
Panel avg: 129d · This submission: 262d
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 K212514.
MEDOJECT fine Pen Needles
K220614 · Chirana T. Injecta · Jun 2022
Well-life TM Pen Needles, Well-life TM Safety Pen Needles
K210748 · W. L. Med Co., Ltd. · May 2022
Sterile Safety Hypodermic Needles for Single Use
K213535 · Zhejiang Kangkang Medical-Devices Co., Ltd. · May 2022
Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder)
K214075 · Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · Apr 2022
Safety Pen Needle
K210864 · Sandstone Medical (Suzhou), Inc. · Feb 2022
DropSafe Safety Pen Needles
K211716 · Htl Strefa SA · Jan 2022