Cleared Traditional

IODOSORB (K190730) - FDA 510(k) Clearance

K190730 · Smith & Nephew Medical, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2019
Decision
274d
Days
-
Risk

K190730 is an FDA 510(k) clearance for the IODOSORB. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Smith & Nephew Medical, Ltd. (Hull, GB). The FDA issued a Cleared decision on December 20, 2019 after a review of 274 days - an extended review cycle.

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 Smith & Nephew Medical, Ltd. devices

Submission Details

510(k) Number K190730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2019
Decision Date December 20, 2019
Days to Decision 274 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
159d slower than avg
Panel avg: 115d · This submission: 274d
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 K190730.
AC5 Topical Gel
K190129 · Arch Therapeutics, Inc. · Mar 2020
Biatain Silicone Ag
K191536 · Coloplast A/S · Feb 2020
Rochal Antimicrobial Wound Gel
K192527 · Rochal Industries, LLC · Feb 2020
IODOFLEX
K190756 · Smith & Nephew Medical, Ltd. · Dec 2019
Hydrofera Blue READY - Border
K190268 · Hydrofera, LLC · Nov 2019
BIAFINE Topical Cream
K190342 · Bausch Health Americas Incorporated · Oct 2019