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

Grass-Telefactor Product Group — Predicate Candidate Screening

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

85 daysmedian FDA review time

163 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K992291	H20- TETHERED OPTION	Grass-Telefactor Product Group	1999-08-06	30
K974583	DEEGLITE	Grass-Telefactor Product Group	1998-06-09	203
K974587	H2O	Grass-Telefactor Product Group	1998-03-09	90
K972202	DEEG-LITE	Grass-Telefactor Product Group	1997-07-23	42
K925838	TELEFACTOR D/EEG-32	Grass-Telefactor Product Group	1993-04-30	163
K884937	BEEHIVE-64 OR BEEHIVE-32, DIGITAL EEG RECORDING	Grass-Telefactor Product Group	1989-04-14	137
K870432	A1-A2 AMBULATORY EEG CASSETTE RECORDER	Grass-Telefactor Product Group	1987-05-08	94
K871480	STD-228 SPECTRAL TREND DISPLAY	Grass-Telefactor Product Group	1987-05-01	17
K870450	SZAC-16 SEIZURE ANALYSIS COMPUTER	Grass-Telefactor Product Group	1987-04-08	64
K870381	DD-VCR-64	Grass-Telefactor Product Group	1987-03-25	55
K860219	SASSSY SEMI AUTOMATIC SLEEP SCORING SYSTEM	Grass-Telefactor Product Group	1986-04-17	85
K860128	MODAC-XXXX INTENSIVE MONITORING OF EEG	Grass-Telefactor Product Group	1986-03-27	72

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