NAD · Class I · 21 CFR 878.4020

FDA Product Code NAD: Dressing, Wound, Occlusive

Leading manufacturers include Chesebrough-Pond'S U.S.A. Co., Smith & Nephew, Inc. and Convatec, A Division of E.R. Squibb & Sons.

108
Total
108
Cleared
91d
Avg days
1977
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 255d recently vs 90d historically

FDA 510(k) Cleared Dressing, Wound, Occlusive Devices (Product Code NAD)

108 devices
1–24 of 108
Cleared Sep 10, 2026
LT Antibacterial Foam with Silver Dressing
K254246
Zhejiang Longterm Medical Technology Co., Ltd.
General & Plastic Surgery · 255d
Cleared Mar 03, 2011
SAM CHEST SEAL WITH VAVLE
K102403
Sam Medical Products
General & Plastic Surgery · 191d
Cleared May 20, 2009
APLION TOPICAL CARE SYSTEM
K091133
Aplion Medical,Llc
General & Plastic Surgery · 30d
Cleared Jun 17, 2008
ENVELA (HYDROHESIVE OCCLUSIVE DRESSING)
K072560
Teikoku Pharma USA, Inc.
General & Plastic Surgery · 280d
Cleared Apr 23, 2008
CENTURION SORBAVIEW OTC
K080524
Tri-State Hospital Supply Corp.
General & Plastic Surgery · 57d
Cleared Feb 27, 2006
DERMASTREAM
K060046
Enzysurge , Ltd.
General & Plastic Surgery · 52d
Cleared Mar 24, 2005
OXYBAND WOUND DRESSING
K043063
Oxyband Technologies, Inc.
General & Plastic Surgery · 139d
Cleared May 06, 2002
WET CHAMBER
K020781
Kinetic Concepts, Inc.
General & Plastic Surgery · 56d
Cleared Jan 31, 2000
KERLIX MD ANTIMICROBIAL GAUZE DRESSING
K990530
The Kendall Company, L.P.
General & Plastic Surgery · 346d
Cleared Apr 12, 1999
WOUND DRESSING/ABD PAD, MODEL #10810
K990861
Hospital Specialty Co.
General & Plastic Surgery · 27d
Cleared Apr 09, 1997
OTOSILK OTOLOGICAL GRAFT DRESSING
K964534
Boston Medical Products, Inc.
General & Plastic Surgery · 148d
Cleared Apr 29, 1996
DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE DRESSING ROLL
K960815
Dumex Medical Surgical Products, Ltd.
General & Plastic Surgery · 61d
Cleared Mar 13, 1996
ALLDRESS MULTI LAYERED WOUND DRESSING
K955863
Molnlycke/Scott Health Care
General & Plastic Surgery · 77d
Cleared Jul 31, 1995
OTOSILK
K952203
Boston Medical Products, Inc.
General & Plastic Surgery · 82d
Cleared Jun 24, 1993
MEDLINE STERILE GAUZE SPONGES
K930697
Medline Industries, Inc.
General & Plastic Surgery · 134d
Cleared Aug 02, 1991
FRASTEC DRYNET, BRIDAL VEIL, VARIOUS SIZES
K912022
Fraass Survival Systems, Inc.
General & Plastic Surgery · 87d
Cleared Mar 06, 1991
MONTROSE DRESSING APPLICATORS
K905519
Olemunda Pty , Ltd.
General & Plastic Surgery · 89d
Cleared Jan 28, 1991
MODIFIED LABELING FOR BIOCLUSIVE* TRANS FILM DRESS
K901853
Johnson & Johnson Medical, Inc.
General & Plastic Surgery · 279d
Cleared Jun 12, 1990
TENSOPLUS LITE
K901378
Smith & Nephew United, Inc.
General & Plastic Surgery · 82d
Cleared Feb 21, 1990
HYDRASORB(TM)
K897156
Avitar, Inc.
General & Plastic Surgery · 57d
Cleared Feb 20, 1990
SORBEX(TM) SOFT SPONGE
K895654
Fountain Pharmaceuticals, Inc.
General & Plastic Surgery · 153d
Cleared Jan 19, 1990
HERMAL WOUND CARE KIT
K895817
Stiefel Research Institute, Inc.
General & Plastic Surgery · 112d
Cleared Nov 01, 1989
2018 ARTERIAL/VENOUS PRESSURE DRESSING
K895845
Advance Medical Designs, Inc.
General & Plastic Surgery · 29d
Cleared Aug 31, 1989
HYPAFIX DRESSING RETENTION SHEET
K894254
Smith & Nephew United, Inc.
General & Plastic Surgery · 72d

About Product Code NAD - Regulatory Context

510(k) Submission Activity

108 total 510(k) submissions under product code NAD since 1977, with 108 receiving FDA clearance (average review time: 91 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - NAD Product Code

Recent submissions under NAD have taken an average of 255 days to reach a decision - up from 90 days historically. Manufacturers should account for longer review timelines in current project planning.

NAD devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →