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

Prentke Romich Co. — Predicate Candidate Screening

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

144 daysmedian FDA review time

270 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K961306	DELTATALKER WITH INFRARED	Prentke Romich Co.	1996-06-27	84
K944585	SCANNING DIRECTOR	Prentke Romich Co.	1995-02-21	155
K935317	ALPHA TALKER	Prentke Romich Co.	1994-03-28	144
K933207	WALKERTALKER	Prentke Romich Co.	1994-03-28	270
K925387	LIBERATOR	Prentke Romich Co.	1993-03-29	154
K925527	LIGHT TALKER	Prentke Romich Co.	1993-03-22	140
K914259	TOUCH TALKER	Prentke Romich Co.	1992-02-27	157
K902664	HOSPITAL/HOME ENVIRONMENTAL CONTROL SYST/HECS-1	Prentke Romich Co.	1990-07-25	37
K902206	CONTROL 1 ENVIRONMENTAL CONTROL	Prentke Romich Co.	1990-05-29	13

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