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

BTS · Predicate Candidate Screening

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

91 daysmedian FDA review time

97 days90th percentile

6clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K953963	RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT &	Rusch, Inc.	1995-11-27	97	0
K951091	RUSCH ENDOBRONCHIAL TUBE SETS	Rusch Intl.	1995-06-08	91	10
K902116	MODIFIED ENDOBRONCHIAL TUBE	Concord/Portex	1990-08-03	85	0
K834565	ENDOBRONCHIAL TWIN LUMEN TUBE	Portex, Inc.	1984-01-17	20	0
K833297	BRONCHOSCOPY TUBE W/ULTRA LOCUFF	Surgitek	1983-12-27	95	0
K771219	BRONCHO-CATH	Mallinckrodt Critical Care	1977-08-04	30	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