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

MPN — Predicate Candidate Screening

36 FDA 510(k) clearances under this product code; the 50 most recent screened below.

173 daysmedian FDA review time

346 days90th percentile

36clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K243990	BondEase 2 Topical Skin Adhesive	Optmed, Inc.	2025-09-19	267	0
K250950	CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Cl	Okapi Medical, LLC Dba Resivant Medical	2025-08-04	129	0
K234114	CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS	Okapi Medical, LLC Dba Resivant Medical	2024-08-20	237	0
K233458	CM005 Standard (CM005); CM004 Mini (CM004)	Connexicon Medical , Ltd.	2024-07-15	266	0
K230981	Meriglu Topical Skin Adhesive	M/s. Meril Endo Surgery Private Limited.	2024-03-16	346	0
K212246	Exofin Precision Pen	Chemence Medical, Inc.	2021-09-09	52	0
K200264	Exofin High Viscosity Topical Skin Adhesive	Chemence Medical, Inc.	2020-12-17	318	0
K183570	LiquiBand Plus	Advanced Medical Solutions Limited	2020-03-09	444	0
K162352	derma+flex QS High Viscosity Tissue Adhesive	Chemence Medical, Inc.	2016-12-22	121	0
K161011	SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Sk	Adhezion Biomedical, LLC	2016-11-08	211	0
K161050	ACTABOND Topical Skin Adhesive	Bergen Medical Products, Inc.	2016-10-04	173	0
K152476	Exofin High Viscosity Tissue Adhesive	Chemence Medical Products, Inc.	2016-02-09	162	0
K150032	GluStitch Twist Tissue Adhesive	Glustitch, Inc.	2016-01-14	371	0
K141157	BONDEASE TOPICAL SKIN ADHESIVE	Optmed, Inc.	2015-12-22	596	0
K151182	LiquiBand Exceed	Advanced Medical Solutions (Plymouth), Ltd.	2015-10-26	175	0
K152096	DERMABOND Advanced Topical Skin Adhesive, High Viscosity DER	ETHICON, Inc.	2015-10-22	86	0
K150866	SURGISEAL Topical Skin Adhesvie	Adhezion Biomedical, LLC	2015-07-17	107	0
K133963	SURGISEAL TWIST (TM) TOPICAL SKIN ADHESIVE	Adhezion Biomedical, LLC	2014-09-09	259	0
K141215	SURGISEAL TWIST TOPICAL SKIN ADHESIVE	Adhezion Biomedical, LLC	2014-08-21	101	0
K140343	AESCULAP HISTOACRYL, HISTOACRYL BLUE AND HISTOACRYL FLEXIBLE	Aesculap, Inc.	2014-05-13	91	0
K140517	SURGISEAL TOPICAL SKIN ADHESIVE/SURGISEAL STYLUS TOPICAL SKI	Adhezion Biomedical, LLC	2014-04-28	59	0
K132243	BARLE TISSUE ADHESIVE 2	Advanced Medical Solutions (Plymouth), Ltd.	2013-12-20	155	1
K130329	SURGISEAL TOPICAL SKIN ADHESIVE	Adhezion Biomedical, LLC	2013-12-03	295	0
K130474	SURGISEAL TOPICAL SKIN ADHESIVE	Adhezion Biomedical, LLC	2013-05-31	95	0
K123133	BARLE TISSUE ADHESIVE	Advanced Medical Solutions (Plymouth), Ltd.	2013-05-22	230	0
K121976	AESCULAP HISTOACRYL FLEXIBLE TOPICAL SKIN ADHESIVE	Aesculap, Inc.	2013-05-17	316	0
K123936	SURGISEAL TOPICAL SKIN ADHESIVE	Adhezion Biomedical, LLC	2013-04-24	125	0
K122446	LIQUIDBAND FLOW CONTROL	Advanced Medical Solutions (Plymouth), Ltd.	2012-10-26	77	1
K111959	AESCULAP HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIV	Aesculap, Inc.	2012-02-06	210	0
K110184	LIQUIBAND FLOW CONTROL	Medlogic Global Limited	2011-12-16	329	0
K102076	LIQUIBAND DUAL, MODEL LBD 001	Medlogic Global Limited	2011-02-18	207	0
K101276	DERMA+FLEX QS HIGH VISCOSITY TISSUE ADHESIVE MODEL: QS70404	Chemence Medical Products, Inc.	2010-07-28	83	0
K100423	DERMABOND NX ADHESIVE MODEL: DNX6, DNX12	ETHICON, Inc.	2010-05-04	77	0
K100284	LIQUIBAND ULTIMA, LUT 003	Medlogic Global Limited	2010-04-09	67	0
K083531	LIQUIBAND ULTIMA, MODEL LB0004	Medlogic Global , Ltd.	2009-02-12	76	0
K082993	SURGISEAL TOPICAL SKIN ADHESIVE	Adhezion Biomedical	2008-12-19	73	0

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