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

Tti Medical — Predicate Candidate Screening

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

80 daysmedian FDA review time

446 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K952006	ACCU-BEAM FIBER OPTIC HANDPIECE	Tti Medical	1995-05-31	33
K951895	ACCU-BEAM 300W XENON LIGHT SOURCE	Tti Medical	1995-05-24	30
K945648	ACCU-BEAM C02 LASER HANDPIECE	Tti Medical	1995-02-24	99
K921208	ACCU-BEAM TUBE SET	Tti Medical	1993-06-01	446
K910978	ACCU-BEAM LAPAROSCOPIC SYSTEM	Tti Medical	1991-11-07	245
K895656	ACCU-BEAM WAVEGUIDE	Tti Medical	1990-02-22	156
K890922	ACCU-BEAM YAG FIBER	Tti Medical	1989-05-15	80
K870063	CO2 LASER BRONCHOSCOPE SET	Tti Medical	1987-03-09	61
K870046	DOUBLE PUNCTURE CO2 LASER LAPAROSCOPY SET	Tti Medical	1987-03-05	59

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