Product Code: NAD FDA class 1 21 CFR 878.4020

Dressing, Wound, Occlusive

General, Plastic Surgery

The Occlusive Wound Dressing is a wound care product that creates an airtight or near-airtight barrier over a wound, preventing moisture evaporation and protecting against external contaminants while maintaining a moist healing environment conducive to tissue repair. Classified as FDA Class 1, it is subject to general controls under regulation 878.4020 (General and Plastic Surgery specialty).

View on FDA

510(k)s

107

FEI Numbers

502

Registration Numbers

502

Unique Applicants

Years Active

Research product code NAD in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: NAD
Device Class: FDA class 1
Regulation Number: 878.4020
Medical Specialty: General, Plastic Surgery
Review Panel: SU
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 107 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K102403	SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL	Mar 03, 2011	Substantially Equivalent	Sam Medical Products
K091133	APLION TOPICAL CARE SYSTEM	May 20, 2009	Substantially Equivalent	Aplion Medical,Llc
K072560	ENVELA (HYDROHESIVE OCCLUSIVE DRESSING)	Jun 17, 2008	Substantially Equivalent	Teikoku Pharma USA, Inc.
K080524	CENTURION SORBAVIEW OTC	Apr 23, 2008	Substantially Equivalent	Tri-State Hospital Supply Corp.
K060046	DERMASTREAM	Feb 27, 2006	Substantially Equivalent	Enzysurge , Ltd.
K043063	OXYBAND WOUND DRESSING	Mar 24, 2005	Substantially Equivalent	Oxyband Technologies, Inc.
K020781	WET CHAMBER	May 06, 2002	Substantially Equivalent	Kinetic Concepts, Inc.
K990530	KERLIX MD ANTIMICROBIAL GAUZE DRESSING	Jan 31, 2000	Substantially Equivalent	The Kendall Company, L.P.
K990861	WOUND DRESSING/ABD PAD, MODEL #10810	Apr 12, 1999	Substantially Equivalent	Hospital Specialty Co.
K964534	OTOSILK OTOLOGICAL GRAFT DRESSING	Apr 09, 1997	Substantially Equivalent	Boston Medical Products, Inc.
K960815	DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE DRESSING ROLL	Apr 29, 1996	Substantially Equivalent	Dumex Medical Surgical Products, Ltd.
K955863	ALLDRESS MULTI LAYERED WOUND DRESSING	Mar 13, 1996	Substantially Equivalent for Some Indications	Molnlycke/Scott Health Care
K952203	OTOSILK	Jul 31, 1995	Substantially Equivalent	Boston Medical Products, Inc.
K930697	MEDLINE STERILE GAUZE SPONGES	Jun 24, 1993	Substantially Equivalent	Medline Industries, Inc.
K912022	FRASTEC DRYNET, BRIDAL VEIL, VARIOUS SIZES	Aug 02, 1991	Substantially Equivalent	Fraass Survival Systems, Inc.
K905519	MONTROSE DRESSING APPLICATORS	Mar 06, 1991	Substantially Equivalent	Olemunda Pty , Ltd.
K901853	MODIFIED LABELING FOR BIOCLUSIVE* TRANS FILM DRESS	Jan 28, 1991	Substantially Equivalent	Johnson & Johnson Medical, Inc.
K901378	TENSOPLUS LITE	Jun 12, 1990	Substantially Equivalent	Smith & Nephew United, Inc.
K897156	HYDRASORB(TM)	Feb 21, 1990	Substantially Equivalent	Avitar, Inc.
K895654	SORBEX(TM) SOFT SPONGE	Feb 20, 1990	Substantially Equivalent for Some Indications	Fountain Pharmaceuticals, Inc.
K895817	HERMAL WOUND CARE KIT	Jan 19, 1990	Substantially Equivalent	Stiefel Research Institute, Inc.
K895845	2018 ARTERIAL/VENOUS PRESSURE DRESSING	Nov 01, 1989	Substantially Equivalent	Advance Medical Designs, Inc.
K894254	HYPAFIX DRESSING RETENTION SHEET	Aug 31, 1989	Substantially Equivalent	Smith & Nephew United, Inc.
K892837	STERIL-DERM TRANSPARENT WOUND DRESSING	Aug 01, 1989	Substantially Equivalent	Biointerface Technologies, Inc.
K891998	BANDAGE, MUSLIN, COMPRESSED, CAMOUFLAGED, 37X37X52	Jun 05, 1989	Substantially Equivalent	Elwyn Industries
K891459	STERILE BURNNET PRE-CUT (VARIOUS SIZES)	May 26, 1989	Substantially Equivalent	Western Medical, Ltd.
K882558	AREOLA/NIPPLE DRESSING	May 24, 1989	Substantially Equivalent	Cooper Surgical/Aesthete
K890603	BEAM TECH WOUND DRESSING*	May 23, 1989	Substantially Equivalent	Beam Tech , Ltd.
K892527	DUODERM* TRANSPARENT HYDROCOLLOID DRESSING-MODIFY	May 11, 1989	Substantially Equivalent	Convatec, A Division of E.R. Squibb & Sons
K891696	DUODERM* EXTRA THIN FLEXIBLE HYDROCOLLOID DRESSING	May 04, 1989	Substantially Equivalent	Convatec, A Division of E.R. Squibb & Sons
K884791	PERME-AID TRANSPARENT DRESSING, #11XX	May 04, 1989	Substantially Equivalent	Nitto Denko Technical Corp.
K890354	TEGAPORE WOUND CONTACT MATERIAL, PRODUCT #563X	Apr 27, 1989	Substantially Equivalent for Some Indications	3M Company
K890940	MODIFIED LABELING FOR POLYDERM WBC(TM)	Apr 17, 1989	Substantially Equivalent	Laivan Corp.
K885325	FRASTEC CONFORMANT DRESSING, VARIOUS SIZES	Apr 17, 1989	Substantially Equivalent for Some Indications	Frastec Wound Care Products, Inc.
K883391	POLYMER ADHESIVE BANDAGE	Mar 23, 1989	Substantially Equivalent for Some Indications	Marion Laboratories, Inc.
K890748	ALLEVYN TRACHEOSTOMY DRESSING	Mar 08, 1989	Substantially Equivalent for Some Indications	Smith & Nephew United, Inc.
K883849	REPLICARE (ADDITIONAL CLAIMS)	Feb 08, 1989	Substantially Equivalent for Some Indications	United Medical
K884440	TECNOL VARIABLE TENSION BANDAGE	Jan 17, 1989	Substantially Equivalent for Some Indications	Tecnol New Jersey Wound Care, Inc.
K881426	PAN-PRA AID SELF-ADHE. COLLO. COATED BANDAGE	Nov 10, 1988	Substantially Equivalent for Some Indications	Laboratoire Pan-Pra
K881936	OPER-FILM-ADHESIVE MEMBRANE	Aug 31, 1988	Substantially Equivalent for Some Indications	Iberhospitex, S.A.
K881731	AD-HEAL(TM) WOUND DRESSING	Aug 31, 1988	Substantially Equivalent for Some Indications	Nepera, Inc.
K882696	DERMICEL, MONTGOMERY STRAP	Aug 26, 1988	Substantially Equivalent	Bioseal
K881988	3M WOUND CONTACT MATERIAL, PRODUCT #563X	Jun 27, 1988	Substantially Equivalent	3M Company
K880153	POLYDERM A+B(TM)	Apr 13, 1988	Substantially Equivalent for Some Indications	Laivan Corp.
K875253	BFGOODRICH BIOTHANE NON-ADHERENT DRESSING	Apr 13, 1988	Substantially Equivalent for Some Indications	The Bfgoodrich Co.
K881050	DUODERM(R) CGF	Apr 01, 1988	Substantially Equivalent for Some Indications	Convatec, A Division of E.R. Squibb & Sons
K880206	POLYDERM WBC (TM), WATERPROOF BREATHABLE COVER	Mar 11, 1988	Substantially Equivalent for Some Indications	Laivan Corp.
K874554	ENVICLUSIVE (TM)	Mar 11, 1988	Substantially Equivalent	Marion Laboratories, Inc.
K872573	PHARMACLUSIVE (TM)	Feb 29, 1988	Substantially Equivalent	Pharmacia, Inc.
K874480	MODIFIED MANUFACTURING PROCESS FOR OMIDERM(TM)	Feb 22, 1988	Substantially Equivalent for Some Indications	Omikron Scientific, Ltd.
K874478	DYNAFILM	Jan 14, 1988	Substantially Equivalent for Some Indications	Ferris Mfg. Corp.
K874470	MWI 400 WOUND DRESSING	Dec 18, 1987	Substantially Equivalent for Some Indications	Med-West, Inc.
K874161	MODIFIED USE OF TRIANGLE BANDAGE STERILE	Dec 04, 1987	Substantially Equivalent	K. W. Griffen Co.
K874291	EPI-LOCK T.M. PRIMADERM	Nov 10, 1987	Substantially Equivalent for Some Indications	Derma-Lock Medical Corp.
K873277	MITRAFLEX(TM) WOUND DRESSING	Sep 17, 1987	Substantially Equivalent for Some Indications	Matrix Medica, Inc.
K872988	TRANSIGEN EXUDATE CONTROLLED WOUND DRESSING	Sep 16, 1987	Substantially Equivalent for Some Indications	Smith & Nephew, Inc.
K872875	STRETCH GAUZE BANDAGES	Sep 04, 1987	Substantially Equivalent	Abco Dealers, Inc.
K872982	JOHNSON & JOHNSON ABSORBENT OCCLUSIVE DRESSING	Aug 14, 1987	Substantially Equivalent for Some Indications	Johnson & Johnson Professionals, Inc.
K872069	KONTOUR ULTRA SOFT SPONGE #SS144.50	Jul 14, 1987	Substantially Equivalent for Some Indications	Winfield Laboratories, Inc.
K872101	BIOFILM TRANS. POUCH ULCER & WOUND DRESSING	Jun 30, 1987	Substantially Equivalent for Some Indications	The Bfgoodrich Co.
K872100	BIOFILM TRANSORBENT ULCER AND WOUND DRESSING	Jun 30, 1987	Substantially Equivalent for Some Indications	The Bfgoodrich Co.
K872099	BIOFILM TRANS. ISLAND, ISLAND ULCER & WOUND DRESS.	Jun 30, 1987	Substantially Equivalent for Some Indications	The Bfgoodrich Co.
K871166	ALLEVYN HYDROPHILIC POLYURETHANE DRESSING	Jun 16, 1987	Substantially Equivalent for Some Indications	Smith & Nephew, Inc.
K871495	BANDAGES CATALOG NUMBER: 101 TO 220	May 08, 1987	Substantially Equivalent	I M, Inc.
K870239	DRESSING, BURN, 24 BY 36 INCHES	Feb 06, 1987	Substantially Equivalent	Fraass Survival Systems, Inc.
K870185	BANDAGE, GAUZE (NONABSOR. GAUZE FOR EXTERNAL USE)	Feb 06, 1987	Substantially Equivalent	Fraass Survival Systems, Inc.
K864688	ARNOLD-KING PRESSURE DRESSING	Jan 12, 1987	Substantially Equivalent	Angiosystems, Inc.
K863580	DERMATEC TRANSPARENT FILM DRESSING	Dec 31, 1986	Substantially Equivalent for Some Indications	Dermatec, Inc.
K863578	DERMATEC ZONE TRANSPARENT DRESSING	Nov 25, 1986	Substantially Equivalent for Some Indications	Dermatec, Inc.
K864011	EXU-DRY BURN/TRAUMA DRESSING, VARIOUS SIZES	Nov 22, 1986	Substantially Equivalent for Some Indications	Fraass Survival Systems, Inc.
K863379	DERMATEC BURN PADS	Sep 26, 1986	Substantially Equivalent for Some Indications	Dermatec, Inc.
K862935	WOUND MANAGER(TM) - STERILE	Aug 20, 1986	Substantially Equivalent for Some Indications	Convatec, A Division of E.R. Squibb & Sons
K861972	DERMISTRIP	Jun 27, 1986	Substantially Equivalent for Some Indications	Kells Medical, Inc.
K860085	LYOFOAM WOUND DRESSINGS	Jun 27, 1986	Substantially Equivalent for Some Indications	Acme United Corp.
K854740	PRIMADERM	Mar 14, 1986	Substantially Equivalent for Some Indications	Absorbent Cotton Co., Inc.
K854850	FALKON STRETCH-STERILE	Jan 13, 1986	Substantially Equivalent	G.B.F. Industries, Inc.
K853334	NON-ADHERA ADHESIVE PAD 3X4	Aug 21, 1985	Substantially Equivalent	American White Cross, Inc.
K852211	OPSITE WOUND DRESSING	Jul 23, 1985	Substantially Equivalent for Some Indications	Smith & Nephew, Inc.
K851383	BLISTERFILM TRANSPARENT DRESSING	Jul 05, 1985	Substantially Equivalent for Some Indications	Chesebrough-Pond'S U.S.A. Co.
K851382	CHESEBROUGH-POND'S SEQUENTIAL WOUND DRESSING	Jul 05, 1985	Substantially Equivalent for Some Indications	Chesebrough-Pond'S U.S.A. Co.
K852091	ALBA DRY BURN PAD	Jun 13, 1985	Substantially Equivalent	Alba-Waldensian, Inc.
K850535	MITRATHANE DRESSING	Jun 05, 1985	Substantially Equivalent for Some Indications	Mitral Medical , Ltd.
K850282	HYPAFIX POST OPERATIVE DRESSING	May 07, 1985	Substantially Equivalent	Smith & Nephew, Inc.
K850904	ALBA DRY BURN DRESSING	Apr 17, 1985	Substantially Equivalent	Alba Health Care
K850076	WOUND DRESSING MODEL ZB-6	Apr 15, 1985	Substantially Equivalent	Thermedics, Inc.
K843200	SITE STRIP	Mar 12, 1985	Substantially Equivalent	E-Med Corp.
K844095	WET DRESSING WATER-STERILE	Nov 27, 1984	Substantially Equivalent	Absorbent Cotton Co., Inc.
K843140	ISOLATE ADHESIVE BANDAGE FOR DRY WOUND	Nov 08, 1984	Substantially Equivalent	Chesebrough-Pond'S U.S.A. Co.
K843139	ISOLATE ADHESIVE BANDAGE FOR MOIST WOUND	Nov 08, 1984	Substantially Equivalent	Chesebrough-Pond'S U.S.A. Co.
K842186	ACU-DERM TRANSPARENT WOUND DRESSING	Aug 24, 1984	Substantially Equivalent	Acme United Corp.
K831703	COVERUPS	Jan 03, 1984	Substantially Equivalent	The Urology Group
K833729	ELASTIC BREATHABLE OVER-WRAP BANDAGE	Dec 30, 1983	Substantially Equivalent	American Medical Disposable, Inc.
K833638	DERMATEX STERILE FINGER BANDAGE	Dec 27, 1983	Substantially Equivalent	Dermatec, Inc.
K831204	MULTIPLE	Nov 28, 1983	Substantially Equivalent	Derma-Lock Medical Corp.
K831454	LASTOBAND ADHESIVE BANDAGES	Oct 31, 1983	Substantially Equivalent	Smith & Nephew, Inc.
K831283	TRIANGLE BANDAGE STERILE	Aug 12, 1983	Substantially Equivalent	Pac-Kit Safety Equipment Co.
K831611	UNI-THANE	Jun 20, 1983	Substantially Equivalent	Carapac Systems, Inc.
K830050	MOLNLYCKE MEPORE STERILE SELF-ADHESIVE	Jun 02, 1983	Substantially Equivalent	Lada Intl., Inc.
K830593	ENSURE DRESSING	Apr 06, 1983	Substantially Equivalent	Warner-Lambert Co.
K823852	CHESEBROUGH-POND'S MULTILAYER ELASTIC	Mar 17, 1983	Substantially Equivalent	Chesebrough-Pond'S U.S.A. Co.
K830089	BURN DRESSING	Mar 08, 1983	Substantially Equivalent	Action Medical Systems, Inc.
K822080	ADHESIVE WOUND COVER FILM	Oct 15, 1982	Substantially Equivalent	Hollister, Inc.
K802021	PEDIBAND CAT.#195-197	Sep 16, 1980	Substantially Equivalent	Pollak (Intl.), Ltd.
K801840	SURGICAL BANDAGES/SUNLEEP DX	Sep 09, 1980	Substantially Equivalent	Martin'S Maine Exchange
K800953	FIXOMULL STERILE	May 20, 1980	Substantially Equivalent	Beiersdorf, Inc.
K791369	AIRSTRIP THEATRE WARD DRESSING	Aug 28, 1979	Substantially Equivalent	Acme United Corp.
K761093	BANDAGE	Jan 06, 1977	Substantially Equivalent	Paco Pharmaceutical Services, Inc.