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

Luxtec Corp. — Predicate Candidate Screening

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

70 daysmedian FDA review time

190 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K973193	LUXSCOPE	Luxtec Corp.	1997-11-21	88	0
K970642	TENOSCOPE	Luxtec Corp.	1997-05-21	90	0
K970562	TENOSNARE	Luxtec Corp.	1997-05-14	90	0
K950960	REDDY ILLUMINATOR	Luxtec Corp.	1995-09-08	190	0
K895248	IMS5000 ILLUMINATED LOUPES	Luxtec Corp.	1989-09-15	25	0
K890716	LUXTEC ACO SERIES 4000 LIGHT SOURCE	Luxtec Corp.	1989-04-26	72	0
K864387	LUXTEC FIBEROPTIC CABLES	Luxtec Corp.	1987-05-22	198	1
K864383	LUXTEC, KILLIAN AND VIENNA NASAL SPECULUMS	Luxtec Corp.	1987-01-14	70	0
K864382	FRAZIER SUCTION TUBE	Luxtec Corp.	1987-01-14	70	0
K864385	LUXTEC LIGHT SOURCES	Luxtec Corp.	1987-01-13	69	1
K864865	SPECULUM, VAGINAL, METAL FIBEROPTIC	Luxtec Corp.	1987-01-09	29	0
K864381	LUXTEC VIDEOLUX 20/20 CAMERA HEADLIGHT SYSTEM	Luxtec Corp.	1986-12-09	34	0
K864384	LUXTEC RETRACTORS, LUXTEC SPECIALTY RETRACTORS	Luxtec Corp.	1986-11-19	14	0
K864380	LUTEX HEADLIGHT SYSTEMS	Luxtec Corp.	1986-11-19	14	8
K864386	LUXTEC LOUPES FOR SURGICAL VISION	Luxtec Corp.	1986-11-17	12	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