Cleared Traditional

K210444 - EZ-Injec LDV Sterile Safety Needle (FDA 510(k) Clearance)

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

K210444 · Poonglim Pharmatech, Inc. · General Hospital
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Feb 2021
Decision
-
Days
Class 2
Risk

K210444 is an FDA 510(k) clearance for the EZ-Injec LDV Sterile Safety Needle. Classified as Low Dead Space Needle, Single Lumen, Hypodermic (product code QNS), Class II - Special Controls.

Submitted by Poonglim Pharmatech, Inc. (Gunsan, KR). The FDA issued a Cleared decision on February 16, 2021.

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 Poonglim Pharmatech, Inc. devices

Submission Details

510(k) Number K210444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2021
Decision Date February 16, 2021
Days to Decision -
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
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QNS Low Dead Space Needle, Single Lumen, Hypodermic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
Definition A Low Dead Space Single Lumen Hypodermic Needle Is A Device Designed To Reduce Medication Waste. The Device Consists Of A Metal Tube That Is Sharpened At One End And At The Other End Joined To Connector Designed To Mate With A Piston Syringe. It May Or May Not Have Needle Safety Features. The Device Can Be Used By Health Care Professions Or For Self-injection By The Patient.
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

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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.