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

DBY · Predicate Candidate Screening

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

78 daysmedian FDA review time

90 days90th percentile

6clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K022067	CONVOY ADVANCED DELIVERY SHEATH	Boston Scientific	2002-09-11	78	1
K013919	TORFLEX TRANSSEPTAL GUIDING SHEATH	Baylis Medical Co., Inc.	2002-02-22	87	1
K013304	BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SH	Becton Dickinson Infusion Therapy Systems, Inc.	2002-01-02	90	0
K013282	GORE INTRODUCER SHEATH	W. L. Gore & Associates, Inc.	2001-12-14	73	0
K013866	CONVOY ADVANCED DELIVERY SHEATH KIT	Boston Scientific	2001-12-14	23	2
K771144	RHODAMINE-CONJUGATED ANTISERUM	Kent Laboratories, Inc.	1977-07-14	17	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