Cleared Traditional

MIS Solution (K203835) - FDA 510(k) Clearance

K203835 · Next Science, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2021
Decision
114d
Days
-
Risk

K203835 is an FDA 510(k) clearance for the MIS Solution. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Next Science, LLC (Jacksonsonville, US). The FDA issued a Cleared decision on April 23, 2021 after a review of 114 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. 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 Next Science, LLC devices

Submission Details

510(k) Number K203835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2020
Decision Date April 23, 2021
Days to Decision 114 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 115d · This submission: 114d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 168
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K203835.
TorrentX Wound Wash
K203446 · Next Science, LLC · Sep 2021
Omeza Collagen Matrix
K211972 · Omeza, LLC · Sep 2021
High Performance Antimicrobial Gelling Fiber with Silver
K210974 · Advanced Medical Solutions, Ltd. · May 2021
AMSure® Single Use Saline Topical Solution
K201138 · Amsino Medical, Inc. · Apr 2021
Antibacterial Bandage
K201324 · Jiangsu Excellence Medical Supplies Co., Ltd. · Feb 2021
LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use)
K201016 · Huizhou Foryou Medical Devices Co., Ltd. · Jan 2021