Cleared Traditional

K201930 - Nanum Syringe

K201930 is an FDA 510(k) clearance for Nanum Syringe, manufactured by Nanum Company Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code FMF cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K201930 · Nanum Company Co., Ltd. · General & Plastic Surgery device
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Jan 2021
Decision
191d
Days
Class 2
Risk

K201930 is an FDA 510(k) clearance for the Nanum Syringe. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Nanum Company Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on January 17, 2021 after a review of 191 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5860 - the FDA general and plastic surgery 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 & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Nanum Company Co., Ltd. devices

FDA 510(k) Submission Details - K201930

510(k) Number K201930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2020
Decision Date January 17, 2021
Days to Decision 191 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 115d · This submission: 191d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 & Plastic Surgery 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 - FMF Syringe, Piston

All 330
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K201930.
MicroDose Injector
K203264 · Medone Surgical, Inc. · Apr 2021
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BD Hypodermic Syringe
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Instylla Delivery Kit
K202544 · Instylla, Inc. · Jan 2021
Insulin Syringe
K193273 · Promisemed Hangzhou Meditech Co., Ltd. · Jan 2021
S dispensing line
K192770 · Aea Srl · Dec 2020