Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Tissuelink Medical, Inc. · Predicate Candidate Screening

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

73 daysmedian FDA review time

90 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K073495	TISSUELINK AQUAMANTYS MALLEABLE BIPOLAR SEALER WITH LIGHT	Tissuelink Medical, Inc.	2008-01-09	28	0
K063639	AQUAMANTYS SS4.0 BIPOLAR SEALER, MODEL 23-121-1	Tissuelink Medical, Inc.	2007-02-22	77	0
K052859	AQUAMANTYS PUMP GENERATOR SYSTEM	Tissuelink Medical, Inc.	2005-10-25	14	1
K032132	TISSUELINK FLOATING BALL MODEL 23-201-1	Tissuelink Medical, Inc.	2003-08-20	40	0
K030380	TISSUELINK SEALING FORCEPS, MODEL 1 21-202-1	Tissuelink Medical, Inc.	2003-03-03	26	0
K022532	TISSUELINK BIPOLAR FLOATING BALL DEVICE	Tissuelink Medical, Inc.	2003-02-12	196	2
K020574	TISSUELINK BIPOLAR FLOATING BALL DEVICE	Tissuelink Medical, Inc.	2002-05-20	88	2
K014260	TISSUELINK SOLID CYLINDER MONOPOLAR DEVICE	Tissuelink Medical, Inc.	2002-03-27	90	1
K010661	MODIFICATION TO TISSUELINK BIPOLAR FORCEPS	Tissuelink Medical, Inc.	2001-05-03	63	0
K010662	MODIFICATION TO TISSUELINK MONOPOLAR FLOATING BALL	Tissuelink Medical, Inc.	2001-04-27	57	0
K003005	TISSUELINK BIPOLAR FORCEPS	Tissuelink Medical, Inc.	2000-12-08	73	0
K002680	TISSUELINK MONOPOLAR FLOATING BALL'	Tissuelink Medical, Inc.	2000-11-13	77	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