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

Smith & Nephew United, Inc. — Predicate Candidate Screening

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

66 daysmedian FDA review time

152 days90th percentile

34clearances measured

K-number	Device	Applicant	Decided	Review days
K963096	ALLEVYN HYDRO POLY DRESSING ND ALL TRAC DRESSING	Smith & Nephew United, Inc.	1996-10-25	77
K961775	PROFORE FOUR-LAYER BANDAGE SYSTEM KIT	Smith & Nephew United, Inc.	1996-07-16	69
K945330	ALLEVYN ADHESIVE	Smith & Nephew United, Inc.	1995-02-09	100
K943619	CAVI-CARE CONFORMING FOAM DRESSING	Smith & Nephew United, Inc.	1994-08-19	23
K942748	INTRASITE	Smith & Nephew United, Inc.	1994-06-29	19
K935705	ALLEVYN ISLAND WOUND DRESSING	Smith & Nephew United, Inc.	1994-02-15	77
K935803	CICA-CARE SILICONE GEL SHEET	Smith & Nephew United, Inc.	1994-02-03	63
K932263	SOLOSITE DERMAL WOUND GEL	Smith & Nephew United, Inc.	1993-10-01	164
K926508	INTRASITE GEL	Smith & Nephew United, Inc.	1993-07-13	195
K922897	STRAPPAL	Smith & Nephew United, Inc.	1992-09-15	91
K914147	ALLEVLYN WOUND DRESSING, MODIFICATION	Smith & Nephew United, Inc.	1992-02-03	140
K915150	REMOVE ADHESIVE REMOVER	Smith & Nephew United, Inc.	1992-01-09	56
K911682	AIRSTRIP FIRST AID & POST-OP DRESSING	Smith & Nephew United, Inc.	1991-07-17	93
K911660	INTRASITE HYDROCOLLOID WOUND DRESSING	Smith & Nephew United, Inc.	1991-06-17	66
K904411	INTRASITE GEL (LABELING REVISION)	Smith & Nephew United, Inc.	1990-11-26	61
K904412	ALLEVYN DRESSING CLAIMS CHANGE	Smith & Nephew United, Inc.	1990-10-23	27
K901876	INTRASITE CAVITY WOUND DRESSING (LABEL REVISION)	Smith & Nephew United, Inc.	1990-06-28	63
K901877	ALLEVYN DRESSING (LABELING REVISED)	Smith & Nephew United, Inc.	1990-06-22	57
K901878	INTRASITE GEL (LABELING REVISION)	Smith & Nephew United, Inc.	1990-06-22	57
K901879	INTRASITE HYDROCOLLOID DRESSING (REVISED LABELING)	Smith & Nephew United, Inc.	1990-06-22	57
K901378	TENSOPLUS LITE	Smith & Nephew United, Inc.	1990-06-12	82
K895408	OPSITE*WOUND (FLEXIGRID APPLICATION SYSTEM)	Smith & Nephew United, Inc.	1989-12-14	99
K893604	TENS PREP	Smith & Nephew United, Inc.	1989-11-21	189
K895354	INTRASITE CAVITY WOUND DRESSING	Smith & Nephew United, Inc.	1989-11-07	67
K895353	OPSITE I.V. 3000	Smith & Nephew United, Inc.	1989-09-28	27
K894254	HYPAFIX DRESSING RETENTION SHEET	Smith & Nephew United, Inc.	1989-08-31	72
K891870	INTRASITE* GEL (3) YEAR SHELF LIFE	Smith & Nephew United, Inc.	1989-08-09	152
K893602	GLASS MERCURY FILLED THERMOMETERS	Smith & Nephew United, Inc.	1989-08-08	85
K893900	PRIMAPORE I.V.	Smith & Nephew United, Inc.	1989-08-03	48
K893603	REMOVE ADHESIVE REMOVER	Smith & Nephew United, Inc.	1989-07-14	59
K891460	NON-ABSORB GAUZE SURG SPONGE & WOUND DRESS/EXT USE	Smith & Nephew United, Inc.	1989-04-17	33
K891101	NON-ABSORBABLE GAUZE, SURGICAL SPONGE & DRESSING	Smith & Nephew United, Inc.	1989-04-17	46
K890672	ABSORBENT GAUZE ROLL	Smith & Nephew United, Inc.	1989-04-07	57
K890748	ALLEVYN TRACHEOSTOMY DRESSING	Smith & Nephew United, Inc.	1989-03-08	23

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