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

GYE — Predicate Candidate Screening

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

66 daysmedian FDA review time

141 days90th percentile

20clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K963195	WIRELESS EEG RECORDING SYSTEM MODEL W32	Cme Telemetrix, Inc.	1997-07-29	348	0
K970659	DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIV	Telediagnostic Systems, Inc.	1997-05-16	84	0
K895895	MODEL 219 TELEMETRY SYSTEM	Mennen Medical, Inc.	1990-02-22	139	0
K891405	BMS-2000 MOBILE EEG SYSTEM	Buckman Co., Inc.	1989-08-02	141	1
K885328	RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVER	Telediagnostic Systems, Inc.	1989-03-22	84	0
K883947	ISO-100 ISOLATION AMPLIFIER	Telediagnostic Systems, Inc.	1988-12-05	77	0
K883461	DAD 16S, DATA ACQUISTION DEVICE 16 CH. SERIES	Biohm, Inc.	1988-11-30	110	0
K874257	S-10 TELEPHONIC POLYSOMNOGRAPH	Telediagnostic Systems, Inc.	1987-12-11	52	0
K871120	M10 EEG MONITOR SCOPE	Telediagnostic Systems, Inc.	1987-05-01	43	0
K860128	MODAC-XXXX INTENSIVE MONITORING OF EEG	Grass-Telefactor Product Group	1986-03-27	72	0
K833880	TELEPHONIC RECEIVER R-10 EEG	Pharmaquest Corp.	1983-11-29	13	0
K833236	TELEPHONE TRANSMITTER T-10 EEG	Pharmaquest Corp.	1983-11-29	105	0
K832304	BRAEGEN III 10-CHANNEL TRANSMITTER-	Electro-Bio-Medical Services, Inc.	1983-08-31	48	0
K813010	EEG TELEPHONE TRANSMITTER, MODEL #T-7	Pharmaquest Corp.	1981-11-16	20	0
K811093	BRAEGEN EEG TRANSMITTER/RECEIVER SYS	Electro-Bio-Medical Services, Inc.	1981-05-05	14	0
K802656	MODEL T-6 EEG TELEPHONE TRANSMITTER	Telediagnostic Systems, Inc.	1980-11-26	33	0
K802657	MODEL AFR EEG TELEPHONE RECEIVER	Telediagnostic Systems, Inc.	1980-11-12	19	0
K792371	TELEMETRY SYSTEM XMT-1 & REC-1	Burdick Corp.	1980-01-31	66	0
K792380	CMS 6000	Physio-Control Corp.	1980-01-04	39	0
K761259	G.E. TELEMETRY MONITORING	General Electric Co.	1976-12-21	6	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