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

Taut, Inc. — Predicate Candidate Screening

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

76 daysmedian FDA review time

179 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K023261	ADAPT BALLOON OPEN ACCESS PORT, MODEL 41244	Taut, Inc.	2002-12-13	74	0
K021731	ADAPT OPEN ACCESS PORT, MODEL 41233	Taut, Inc.	2002-08-08	76	2
K011018	TAUT BALLOON CATHETER, MODEL 50640	Taut, Inc.	2001-06-22	79	0
K003703	TAUT-INSUFFLATION NEEDLE	Taut, Inc.	2001-02-22	83	0
K010007	ADAPT LAPAROSCOPIC PORT & ADAPT REDUCER CAP	Taut, Inc.	2001-02-22	51	3
K992904	MINI-PORT	Taut, Inc.	1999-10-05	36	0
K992907	INTRADUCER	Taut, Inc.	1999-10-05	36	0
K972112	INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450	Taut, Inc.	1997-12-01	179	0
K962003	TUAT SPLATTER CONTROL SHIELD SCS-300	Taut, Inc.	1996-07-18	57	0
K960883	INTRADUCER PERITONEAL CATHETER 6FRX3, 9FRX3 1/2, 10FRX4, 12F	Taut, Inc.	1996-03-20	15	1
K945486	SPLATTER CONTROL SHIELD	Taut, Inc.	1995-02-28	112	0
K924981	OPERATIVE CHOLANGIOGRAM CATHETER	Taut, Inc.	1993-04-06	187	0
K921934	INTRADUCER	Taut, Inc.	1992-07-15	82	0
K920040	INTRADUCER	Taut, Inc.	1992-02-28	53	0
K875082	O.P.C. INTRAVASCULAR CATHETER	Taut, Inc.	1988-03-08	90	0
K830573	PRE VUE	Taut, Inc.	1983-03-29	34	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