Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

KMI — Predicate Candidate Screening

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

106 daysmedian FDA review time

226 days90th percentile

31clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K141877	LEAF PATIENT MONITORING SYSTEM	Leaf Healthcare, Inc.	2014-11-10	122	0
K131585	INTEL-GE CARE INNOVATIONS QUIETCARE	Intel-Ge Care Innovations, LLC	2013-10-08	130	0
K130752	DYNASENSE SYSTEM	Centauri Medical, Inc.	2013-08-15	149	0
K101109	VIVATRAK	Wireless Medcare, LLC	2010-07-15	86	0
K090138	MOBILECARE MONITOR, MODEL 2100	Aframe Digital, Inc.	2009-04-24	93	0
K942770	ULTIMAT-SENSOR FOR BED OCCUPANCY MONITOR	Ultimate Development Corp.	1994-12-23	193	0
K943481	INFORMER PLUS	Micro-Tech Medical, Inc.	1994-11-02	106	0
K933552	PM-PAGER	Hill Engineering	1994-09-22	428	0
K934344	HOME AMB-ALERT	Medway	1994-04-29	233	0
K940405	TELETOM	Berchtold Holding GmbH	1994-04-14	77	0
K924433	SENIOR TECH TABS 88 TRANS RA1/WRA1/R1 ANN TYPE CR1	Senior Technologies, Inc.	1993-06-24	296	0
K925529	WANDER CARE	Care Electronics, Inc.	1993-06-16	226	0
K920206	POSEY SITTER	J. T. Posey Co.	1992-05-14	119	0
K914859	BARTRONIX IN-BED ACTIVITY MONITOR	Bartronix	1992-04-13	167	0
K911079	AMB-ALERT	Medway	1991-09-13	186	0
K905586	RSVP RF-2000	Tactilitics, Inc.	1991-04-01	116	0
K905421	EXIT ALARM	Alertcare	1991-02-12	70	0
K901969	ALERT BED ALARM SYSTEM	Alertronics, Inc.	1990-09-12	134	0
K901330	THE MONITOR ELECTRONIC BED ALARM SYSTEM	The Monitor Corp.	1990-08-30	161	0
K883390	PMD SYSTEM-20	Datatek, Inc.	1988-10-25	77	0
K873806	JDM SP2 SENSOR	Jd Monitoring C/O Mackler, Cooper and Gibbs	1987-12-08	81	4
K872358	STA-PUT	Design Technologies, Inc.	1987-08-06	49	0
K871203	BED PATIENT PRESENCE MONITOR	Human Technologies, Inc.	1987-05-26	62	0
K864827	RSVP SYSTEMS, SERIES I, BED-PATIENT MONITOR	Tactilitics, Inc.	1987-01-21	43	0
K860537	THE CELL CARE SYSTEM	The Clell Corp.	1986-04-17	65	0
K854950	BED PATIENT MONITOR	Clearview Electronics Corp.	1986-03-25	105	0
K841672	FALL-SAFE VEST	Fsm Corp.	1984-07-03	71	0
K841671	FALL-SAFE MONITOR	Fsm Corp.	1984-07-03	71	0
K840295	AMBULARM	Rigi Systems, Inc.	1984-05-07	104	0
K823926	BED-CHECK: II-IFAC	Bed-Check Corp.	1983-04-18	110	0
K770695	MONITOR, BED, TECHNOLICS	Technolics, Inc.	1977-07-14	90	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