Atlas FDA

NAD

107 FDA 510(k) clearances · Product code

72 daysmedian time to decision
191 days90th percentile
107clearances measured

FDA profile

Official device name
Dressing, Wound, Occlusive
Device class
Class I (low risk)
Regulation
21 CFR 878.4020
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2021: 451 · 2022: 403 · 2023: 1,619 · 2024: 1,804 · 2025: 2,667 · 2026: 1,528
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL (K102403)Sam Medical Products2011-03-03
APLION TOPICAL CARE SYSTEM (K091133)Aplion Medical,Llc2009-05-20
ENVELA (HYDROHESIVE OCCLUSIVE DRESSING) (K072560)Teikoku Pharma USA, Inc.2008-06-17
CENTURION SORBAVIEW OTC (K080524)Tri-State Hospital Supply Corp.2008-04-23
DERMASTREAM (K060046)Enzysurge , Ltd.2006-02-27
OXYBAND WOUND DRESSING (K043063)Oxyband Technologies, Inc.2005-03-24
WET CHAMBER (K020781)Kinetic Concepts, Inc.2002-05-06
KERLIX MD ANTIMICROBIAL GAUZE DRESSING (K990530)The Kendall Company, L.P.2000-01-31
WOUND DRESSING/ABD PAD, MODEL #10810 (K990861)Hospital Specialty Co.1999-04-12
OTOSILK OTOLOGICAL GRAFT DRESSING (K964534)Boston Medical Products, Inc.1997-04-09
DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE DRESSING ROLL (K960815)Dumex Medical Surgical Products, Ltd.1996-04-29
ALLDRESS MULTI LAYERED WOUND DRESSING (K955863)Molnlycke/Scott Health Care1996-03-13
OTOSILK (K952203)Boston Medical Products, Inc.1995-07-31
MEDLINE STERILE GAUZE SPONGES (K930697)Medline Industries, Inc.1993-06-24
FRASTEC DRYNET, BRIDAL VEIL, VARIOUS SIZES (K912022)Fraass Survival Systems, Inc.1991-08-02
MONTROSE DRESSING APPLICATORS (K905519)Olemunda Pty , Ltd.1991-03-06
MODIFIED LABELING FOR BIOCLUSIVE* TRANS FILM DRESS (K901853)Johnson & Johnson Medical, Inc.1991-01-28
TENSOPLUS LITE (K901378)Smith & Nephew United, Inc.1990-06-12
HYDRASORB(TM) (K897156)Avitar, Inc.1990-02-21
SORBEX(TM) SOFT SPONGE (K895654)Fountain Pharmaceuticals, Inc.1990-02-20
HERMAL WOUND CARE KIT (K895817)Stiefel Research Institute, Inc.1990-01-19
2018 ARTERIAL/VENOUS PRESSURE DRESSING (K895845)Advance Medical Designs, Inc.1989-11-01
HYPAFIX DRESSING RETENTION SHEET (K894254)Smith & Nephew United, Inc.1989-08-31
STERIL-DERM TRANSPARENT WOUND DRESSING (K892837)Biointerface Technologies, Inc.1989-08-01
BANDAGE, MUSLIN, COMPRESSED, CAMOUFLAGED, 37X37X52 (K891998)Elwyn Industries1989-06-05
STERILE BURNNET PRE-CUT (VARIOUS SIZES) (K891459)Western Medical, Ltd.1989-05-26
AREOLA/NIPPLE DRESSING (K882558)Cooper Surgical/Aesthete1989-05-24
BEAM TECH WOUND DRESSING* (K890603)Beam Tech , Ltd.1989-05-23
DUODERM* TRANSPARENT HYDROCOLLOID DRESSING-MODIFY (K892527)Convatec, A Division of E.R. Squibb & Sons1989-05-11
DUODERM* EXTRA THIN FLEXIBLE HYDROCOLLOID DRESSING (K891696)Convatec, A Division of E.R. Squibb & Sons1989-05-04
PERME-AID TRANSPARENT DRESSING, #11XX (K884791)Nitto Denko Technical Corp.1989-05-04
TEGAPORE WOUND CONTACT MATERIAL, PRODUCT #563X (K890354)3M Company1989-04-27
MODIFIED LABELING FOR POLYDERM WBC(TM) (K890940)Laivan Corp.1989-04-17
FRASTEC CONFORMANT DRESSING, VARIOUS SIZES (K885325)Frastec Wound Care Products, Inc.1989-04-17
POLYMER ADHESIVE BANDAGE (K883391)Marion Laboratories, Inc.1989-03-23
ALLEVYN TRACHEOSTOMY DRESSING (K890748)Smith & Nephew United, Inc.1989-03-08
REPLICARE (ADDITIONAL CLAIMS) (K883849)United Medical1989-02-08
TECNOL VARIABLE TENSION BANDAGE (K884440)Tecnol New Jersey Wound Care, Inc.1989-01-17
PAN-PRA AID SELF-ADHE. COLLO. COATED BANDAGE (K881426)Laboratoire Pan-Pra1988-11-10
AD-HEAL(TM) WOUND DRESSING (K881731)Nepera, Inc.1988-08-31
OPER-FILM-ADHESIVE MEMBRANE (K881936)Iberhospitex, S.A.1988-08-31
DERMICEL, MONTGOMERY STRAP (K882696)Bioseal1988-08-26
3M WOUND CONTACT MATERIAL, PRODUCT #563X (K881988)3M Company1988-06-27
BFGOODRICH BIOTHANE NON-ADHERENT DRESSING (K875253)The Bfgoodrich Co.1988-04-13
POLYDERM A+B(TM) (K880153)Laivan Corp.1988-04-13
DUODERM(R) CGF (K881050)Convatec, A Division of E.R. Squibb & Sons1988-04-01
ENVICLUSIVE (TM) (K874554)Marion Laboratories, Inc.1988-03-11
POLYDERM WBC (TM), WATERPROOF BREATHABLE COVER (K880206)Laivan Corp.1988-03-11
PHARMACLUSIVE (TM) (K872573)Pharmacia, Inc.1988-02-29
MODIFIED MANUFACTURING PROCESS FOR OMIDERM(TM) (K874480)Omikron Scientific, Ltd.1988-02-22
DYNAFILM (K874478)Ferris Mfg. Corp.1988-01-14
MWI 400 WOUND DRESSING (K874470)Med-West, Inc.1987-12-18
MODIFIED USE OF TRIANGLE BANDAGE STERILE (K874161)K. W. Griffen Co.1987-12-04
EPI-LOCK T.M. PRIMADERM (K874291)Derma-Lock Medical Corp.1987-11-10
MITRAFLEX(TM) WOUND DRESSING (K873277)Matrix Medica, Inc.1987-09-17
TRANSIGEN EXUDATE CONTROLLED WOUND DRESSING (K872988)Smith & Nephew, Inc.1987-09-16
STRETCH GAUZE BANDAGES (K872875)Abco Dealers, Inc.1987-09-04
JOHNSON & JOHNSON ABSORBENT OCCLUSIVE DRESSING (K872982)Johnson & Johnson Professionals, Inc.1987-08-14
KONTOUR ULTRA SOFT SPONGE #SS144.50 (K872069)Winfield Laboratories, Inc.1987-07-14
BIOFILM TRANSORBENT ULCER AND WOUND DRESSING (K872100)The Bfgoodrich Co.1987-06-30
BIOFILM TRANS. ISLAND, ISLAND ULCER & WOUND DRESS. (K872099)The Bfgoodrich Co.1987-06-30
BIOFILM TRANS. POUCH ULCER & WOUND DRESSING (K872101)The Bfgoodrich Co.1987-06-30
ALLEVYN HYDROPHILIC POLYURETHANE DRESSING (K871166)Smith & Nephew, Inc.1987-06-16
BANDAGES CATALOG NUMBER: 101 TO 220 (K871495)I M, Inc.1987-05-08
BANDAGE, GAUZE (NONABSOR. GAUZE FOR EXTERNAL USE) (K870185)Fraass Survival Systems, Inc.1987-02-06
DRESSING, BURN, 24 BY 36 INCHES (K870239)Fraass Survival Systems, Inc.1987-02-06
ARNOLD-KING PRESSURE DRESSING (K864688)Angiosystems, Inc.1987-01-12
DERMATEC TRANSPARENT FILM DRESSING (K863580)Dermatec, Inc.1986-12-31
DERMATEC ZONE TRANSPARENT DRESSING (K863578)Dermatec, Inc.1986-11-25
EXU-DRY BURN/TRAUMA DRESSING, VARIOUS SIZES (K864011)Fraass Survival Systems, Inc.1986-11-22
DERMATEC BURN PADS (K863379)Dermatec, Inc.1986-09-26
WOUND MANAGER(TM) - STERILE (K862935)Convatec, A Division of E.R. Squibb & Sons1986-08-20
LYOFOAM WOUND DRESSINGS (K860085)Acme United Corp.1986-06-27
DERMISTRIP (K861972)Kells Medical, Inc.1986-06-27
PRIMADERM (K854740)Absorbent Cotton Co., Inc.1986-03-14
FALKON STRETCH-STERILE (K854850)G.B.F. Industries, Inc.1986-01-13
NON-ADHERA ADHESIVE PAD 3X4 (K853334)American White Cross, Inc.1985-08-21
OPSITE WOUND DRESSING (K852211)Smith & Nephew, Inc.1985-07-23
BLISTERFILM TRANSPARENT DRESSING (K851383)Chesebrough-Pond'S U.S.A. Co.1985-07-05
CHESEBROUGH-POND'S SEQUENTIAL WOUND DRESSING (K851382)Chesebrough-Pond'S U.S.A. Co.1985-07-05
ALBA DRY BURN PAD (K852091)Alba-Waldensian, Inc.1985-06-13
MITRATHANE DRESSING (K850535)Mitral Medical , Ltd.1985-06-05
HYPAFIX POST OPERATIVE DRESSING (K850282)Smith & Nephew, Inc.1985-05-07
ALBA DRY BURN DRESSING (K850904)Alba Health Care1985-04-17
WOUND DRESSING MODEL ZB-6 (K850076)Thermedics, Inc.1985-04-15
SITE STRIP (K843200)E-Med Corp.1985-03-12
WET DRESSING WATER-STERILE (K844095)Absorbent Cotton Co., Inc.1984-11-27
ISOLATE ADHESIVE BANDAGE FOR DRY WOUND (K843140)Chesebrough-Pond'S U.S.A. Co.1984-11-08
ISOLATE ADHESIVE BANDAGE FOR MOIST WOUND (K843139)Chesebrough-Pond'S U.S.A. Co.1984-11-08
ACU-DERM TRANSPARENT WOUND DRESSING (K842186)Acme United Corp.1984-08-24
COVERUPS (K831703)The Urology Group1984-01-03
ELASTIC BREATHABLE OVER-WRAP BANDAGE (K833729)American Medical Disposable, Inc.1983-12-30
DERMATEX STERILE FINGER BANDAGE (K833638)Dermatec, Inc.1983-12-27
MULTIPLE (K831204)Derma-Lock Medical Corp.1983-11-28
LASTOBAND ADHESIVE BANDAGES (K831454)Smith & Nephew, Inc.1983-10-31
TRIANGLE BANDAGE STERILE (K831283)Pac-Kit Safety Equipment Co.1983-08-12
UNI-THANE (K831611)Carapac Systems, Inc.1983-06-20
MOLNLYCKE MEPORE STERILE SELF-ADHESIVE (K830050)Lada Intl., Inc.1983-06-02
ENSURE DRESSING (K830593)Warner-Lambert Co.1983-04-06
CHESEBROUGH-POND'S MULTILAYER ELASTIC (K823852)Chesebrough-Pond'S U.S.A. Co.1983-03-17
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Every clearance here is in the API, with alerts when new ones post.