Cleared Traditional

Well-life TM Pen Needles, Well-life TM Safety Pen Needles (K210748) - FDA 510(k) Clearance

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

K210748 · W. L. Med Co., Ltd. · General Hospital
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Optimized for regulatory review, auditing and printing
May 2022
Decision
439d
Days
Class 2
Risk

K210748 is an FDA 510(k) clearance for the Well-life TM Pen Needles, Well-life TM Safety Pen Needles. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by W. L. Med Co., Ltd. (Anseong-Si, KR). The FDA issued a Cleared decision on May 25, 2022 after a review of 439 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all W. L. Med Co., Ltd. devices

Submission Details

510(k) Number K210748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2021
Decision Date May 25, 2022
Days to Decision 439 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
310d slower than avg
Panel avg: 129d · This submission: 439d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Plusglobal
Peter Chung

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 201
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K210748.
Insulin Pen Needle
K221176 · Tianjin Huahong Technology Co., Ltd. · Jul 2022
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MEDOJECT fine Pen Needles
K220614 · Chirana T. Injecta · Jun 2022
Sterile Safety Hypodermic Needles for Single Use
K213535 · Zhejiang Kangkang Medical-Devices Co., Ltd. · May 2022
Safety Pen Needle for Single Use, Insulin Pen Needles
K212514 · Berpu Medical Technology Co., Ltd. · Apr 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