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

Fasstech — Predicate Candidate Screening

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

87 daysmedian FDA review time

415 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K063447	INSIGHT DISCOVERY	Fasstech	2007-08-16	274
K033452	CWAS 1000	Fasstech	2003-11-28	29
K023209	INSIGHT MILLENNIUM III	Fasstech	2003-10-10	379
K011964	INSIGHT MILLENNIUM PLUS	Fasstech	2001-09-20	87
K011983	INSIGHT GENESIS	Fasstech	2001-08-30	65
K990778	INSIGHT MILLENNIUM	Fasstech	1999-06-03	86
K961212	SPINAL TOUCH	Fasstech	1996-06-12	76
K940050	FOCUS EMG	Fasstech	1995-02-24	415
K925197	PSI 220 DUAL EMG	Fasstech	1993-02-02	110

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