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

QGH — Predicate Candidate Screening

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

208 daysmedian FDA review time

372 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K192834	MECTA Sigma	Mecta Corporation	2020-04-26	207
K965070	SPECTRUM 5000 Q, 5000Q,M,4000 Q, 4000 M.	Mecta Corp.	1997-03-06	85
K960754	SPECTRUM 5000 Q, 5000 M, 4000 Q, 4000 M	Mecta Corp.	1996-09-18	208
K945120	THYMATRON 2000 ELECTROCONVULSIVE SYSTEM	Somatics, Inc.	1995-10-26	372
K911144	MF-500, MODIFICATION	Elcot, Inc.	1991-10-18	235
K863815	ELECTROCONVULSIVE THERAPY DEVICE, MODEL MF-1000	Elcot, Inc.	1987-06-02	245
K860467	ELECTROSHOCK UNIT NEUROLOGY MODEL B-25	Medcraft Corp.	1986-11-10	277
K852069	MECTA ECT DEVICE MODELS SR & JR	Mecta Corp.	1985-08-09	91
K843923	THYMATRON	Somatics, Inc.	1984-12-03	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