Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Beiersdorf, Inc. — Predicate Candidate Screening

45 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

92 daysmedian FDA review time

245 days90th percentile

45clearances measured

K-number	Device	Applicant	Decided	Review days
K090921	ANTI-EMBOLISM STOCKINGS, MODELS 71055-00000-02, 71057-00000-	Beiersdorf, Inc.	2009-12-18	261
K024057	CURAD SCAR THERAPY	Beiersdorf, Inc.	2003-06-18	191
K952526	CUTINOVA CAVITY	Beiersdorf, Inc.	1995-08-14	74
K943363	CUTIPLAST STERIL	Beiersdorf, Inc.	1995-03-15	245
K944581	CUTINOVA THIN WOUND DRESSING	Beiersdorf, Inc.	1994-12-02	74
K935630	NORTA	Beiersdorf, Inc.	1994-10-07	318
K940378	COVERLET ADHESIVE DRESSING	Beiersdorf, Inc.	1994-07-29	184
K925630	ELASTOPLAST HEAT PLASTER	Beiersdorf, Inc.	1994-02-25	476
K926399	CUTIFILM(R) FILM	Beiersdorf, Inc.	1993-11-15	329
K923404	LUEKOFLEX SURGICAL TAPE	Beiersdorf, Inc.	1992-09-09	61
K921759	ACRYLASTIC	Beiersdorf, Inc.	1992-08-10	118
K921760	TRICOPLAST	Beiersdorf, Inc.	1992-08-10	118
K905688	CUTINOVA HYDRO	Beiersdorf, Inc.	1991-04-01	103
K910274	ARTIFLEX(TM)	Beiersdorf, Inc.	1991-03-05	41
K904500	ELASTOPLAST	Beiersdorf, Inc.	1990-11-21	50
K896891	LEUKOSILK(TM) SURGICAL TAPE	Beiersdorf, Inc.	1990-02-09	63
K894367	LEUKOSPORT(TM) ADHESIVE TAPE	Beiersdorf, Inc.	1989-11-15	124
K885279	CUTINOVA(R) PLUS ON VASCULAR STASIS ULCERS	Beiersdorf, Inc.	1989-06-13	172
K881509	LEUKOPOR(TM) SURGICAL TAPE	Beiersdorf, Inc.	1988-04-22	11
K873744	LEUKOCLIP(R)	Beiersdorf, Inc.	1987-09-30	14
K872975	LIGHTPLAST(TM)	Beiersdorf, Inc.	1987-08-13	14
K864913	CUTINOVA(R) PLUS FOAM GELFILM	Beiersdorf, Inc.	1987-07-24	220
K870504	NORTA (TM) UROBAG	Beiersdorf, Inc.	1987-04-01	56
K864160	LEUKOPLAST(R) POROUS AND SPORT TAPE	Beiersdorf, Inc.	1986-11-17	25
K861181	NORTA TEFLON COATED LATEX BALLOON CATHETERS	Beiersdorf, Inc.	1986-04-08	8
K850147	CUTINOVA GELFILM SYNTHETIC WOUND DRESSING, STERILE	Beiersdorf, Inc.	1985-07-05	172
K843874	LEUKOPOR SURGICAL TAPE	Beiersdorf, Inc.	1985-02-21	142
K843876	LEUKOFLEX SURGICAL TAPE	Beiersdorf, Inc.	1985-02-21	142
K843875	LEUKOSILK	Beiersdorf, Inc.	1985-02-21	142
K843873	LEUKOFIX R	Beiersdorf, Inc.	1985-02-21	142
K842420	NORTA SILICONIZED LATEX BALLOON CATH.	Beiersdorf, Inc.	1984-11-21	154
K842967	AQUAPHOR R GAUZE	Beiersdorf, Inc.	1984-11-08	104
K841559	CONFORMA	Beiersdorf, Inc.	1984-07-17	92
K831438	ELASTOPLAST	Beiersdorf, Inc.	1983-11-25	204
K831439	ELASTOPLAST T.P.N.	Beiersdorf, Inc.	1983-09-29	147
K823879	COVER-ROLL STRETCH	Beiersdorf, Inc.	1983-03-09	72
K823793	ABC BRAND	Beiersdorf, Inc.	1983-01-14	29
K800953	FIXOMULL STERILE	Beiersdorf, Inc.	1980-05-20	27
K792725	FIXOMULL	Beiersdorf, Inc.	1980-03-05	65
K792726	LEUKOFIX POROS	Beiersdorf, Inc.	1980-02-28	59
K792667	LEUKOCLIP POROS	Beiersdorf, Inc.	1980-01-16	20
K792666	LEUKOPOR	Beiersdorf, Inc.	1980-01-16	20
K792360	HANSAPOR STERILE	Beiersdorf, Inc.	1979-12-31	40
K781931	TAPE, ELASTOPLAST ELASTIC TEAR	Beiersdorf, Inc.	1978-12-07	17
K771758	ELASTOMULL GAUZE BANDAGE	Beiersdorf, Inc.	1977-10-13	24

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda