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

General Devices — Predicate Candidate Screening

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

91 daysmedian FDA review time

338 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K013533	EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000)	General Devices	2002-01-18	87
K002089	ROSETTA-LT/ROSETTA-RX	General Devices	2000-11-21	133
K993202	EIM-107 PREP-CHECK	General Devices	1999-12-17	84
K940009	GEMSCOM SERIES 6000, MODELS 6100, 6200 & 6300	General Devices	1995-04-14	465
K935839	GEMSCOM SERIES 5000,	General Devices	1994-11-10	338
K921929	GEMSCOM SERIES 300 12-LEAD ECG (12-LEAD OPTION)	General Devices	1992-09-18	147
K914889	GEMSCOM SERIES 3000	General Devices	1992-03-04	125
K912008	TRU-VIEW MULTI-CHANNEL DISPLAY	General Devices	1991-10-09	156
K896153	MODIFIED DR-2C/PMC 100	General Devices	1990-01-19	87
K862596	DR-2C (MODIFICATION)	General Devices	1986-09-26	91
K844650	DR-2C	General Devices	1985-01-22	54
K830877	AP-CHECK	General Devices	1983-06-08	82
K830876	PREP-CHECK	General Devices	1983-05-18	61

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