Cleared Traditional

BARD OCCLUSIVE WOUND DRESSING (K850889) - FDA 510(k) Clearance

K850889 · C.R. Bard, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1985
Decision
123d
Days
-
Risk

K850889 is an FDA 510(k) clearance for the BARD OCCLUSIVE WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by C.R. Bard, Inc. (Murray Hill, US). The FDA issued a Cleared decision on July 5, 1985 after a review of 123 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K850889 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 04, 1985
Decision Date July 05, 1985
Days to Decision 123 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 115d · This submission: 123d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 701
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K850889.
StatSeal Disc
K254073 · Merit Medical Systems, Inc. · May 2026
IWD-Gel™
K254191 · InnovaCorium, Inc. · Apr 2026
MiraChlor Antimicrobial Wound Solution
K252023 · Letus Corporation · Mar 2026
Promogran Prisma™ Collagen Matrix with ORC and Silver
K251999 · Solventum Germany GmbH · Mar 2026
LUOFUCON® Antimicrobial Wound Gel
K252028 · Huizhou Foryou Medical Co., Ltd. · Mar 2026
Redermax Antibacterial Wound Matrix
K251582 · Beijing Kreate Medical Co., Ltd. · Feb 2026