Cleared Traditional

Nanum Syringe (K201930) - FDA 510(k) Clearance

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

K201930 · Nanum Company Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 241
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
MiniLoad Syringe
K202432 · Ocuject, LLC · Feb 2021
BD Hypodermic Syringe
K203453 · Becton, Dickinson and Company · Jan 2021
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