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

IQA — Predicate Candidate Screening

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

59 daysmedian FDA review time

115 days90th percentile

24clearances measured

K-number	Device	Applicant	Decided	Review days
K961306	DELTATALKER WITH INFRARED	Prentke Romich Co.	1996-06-27	84
K953905	IMPERIUM	Teledyne Brown Engineering	1995-11-21	95
K953937	LIAISON COMPUTER ACCESS & ENVIRONMENTAL CONTROL SYSTEM	Apt Technology, Inc.	1995-10-31	74
K943244	DEUCE	Apt Technology, Inc.	1995-09-11	432
K944585	SCANNING DIRECTOR	Prentke Romich Co.	1995-02-21	155
K944345	BEDSIDE BUTLER	Trac Medical, Inc.	1994-10-17	41
K940223	LEARN MODE WATERPROOF PENDANT PANIC BUTTON	Interactive Technologies, Inc.	1994-04-29	101
K926029	INFRA-LINK	Zygo Industries, Inc.	1993-03-26	115
K921528	HILL-ROM PATIENT ENVIRONMENTAL CONTROL SYSTEM	Hill-Rom, Inc.	1992-04-20	18
K911101	TONGUETOUCH KEYPAD AND ZOFCOM CONTROL SYSTEM	Zofcom, Inc.	1991-04-25	43
K902664	HOSPITAL/HOME ENVIRONMENTAL CONTROL SYST/HECS-1	Prentke Romich Co.	1990-07-25	37
K901028	ENVIRONMENTAL CONTROL UNIT MODEL 7000	Baylor Biomedical Services	1990-03-13	7
K900969	REMOTE CONTROL SWITCH	Baylor Biomedical Services	1990-03-13	11
K890596	MED-A-CALL ASSIST DEVICE	Silent Call Corp.	1989-03-14	46
K881634	SIMPLICITY SERIES 5	Quartet Technology, Inc.	1988-05-17	33
K873612	IMSI, VITAL CALL	Intl. Management Services, Inc.	1987-11-23	76
K872936	97-D EMERSON DIMMER CONTROL	J. H. Emerson Co.	1987-09-24	59
K872937	97-TD EMERSON TIMER/DIMMER CONTROL	J. H. Emerson Co.	1987-09-24	59
K851740	EZZIE SYSTEM	Independent Living, Inc.	1985-07-15	77
K850313	TELEVISION CONTROL OPTION 1219	Rehab Technology, Inc.	1985-04-25	90
K850314	TELEVISION CONTROL OPTION 1220	Rehab Technology, Inc.	1985-04-25	90
K840808	ECU 1218	Rehab Technology, Inc.	1984-03-19	24
K832057	NURSE CALL BUTTON	Qa Alert Systems	1983-07-12	15
K770028	ENVIRONMENTAL CONTROL SYSTEMS	Possum, Inc.	1977-01-12	6

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