Cleared Traditional

FEELject LDV (Low dead volume) syringe (K213010) - FDA 510(k) Clearance

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

K213010 · Feeltech Co., Ltd. · General Hospital
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May 2023
Decision
618d
Days
Class 2
Risk

K213010 is an FDA 510(k) clearance for the FEELject LDV (Low dead volume) syringe. Classified as Low Dead Space Piston Syringe (product code QNQ), Class II - Special Controls.

Submitted by Feeltech Co., Ltd. (Gunsan-Si, KR). The FDA issued a Cleared decision on May 31, 2023 after a review of 618 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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 Feeltech Co., Ltd. devices

Submission Details

510(k) Number K213010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2021
Decision Date May 31, 2023
Days to Decision 618 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
489d slower than avg
Panel avg: 129d · This submission: 618d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QNQ Low Dead Space Piston Syringe
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
Definition A Low Dead Space Syringe Is A Piston Syringe Designed To Reduce Medication Waste. The Device Consists Of A Calibrated Hollow Barrel, A Moveable Plunger, And May Include A Needle. 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

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 - QNQ Low Dead Space Piston Syringe

All 11
Devices cleared under the same product code (QNQ) and FDA review panel - the closest regulatory comparables to K213010.
PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe
K241190 · Poonglim Pharmatech, Inc. · May 2024
TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))
K231856 · Medexel Co.,Ltd · Mar 2024
PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe
K221860 · Poonglim Pharmatech, Inc. · Sep 2023
Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe
K213013 · Jeil Tech Co., Ltd. · Sep 2022
LDV((Low Dead Volume )Syringe
K220083 · Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · May 2022
PLPT LDV (Low Dead Volume) Sterile Syringe
K210443 · Poonglim Pharmatech, Inc. · Feb 2021