Product Code: KMI FDA class 1 21 CFR 880.2400

Monitor, Bed Patient

General Hospital

A Bed Patient Monitor is a device used in hospital and long-term care settings to detect patient movement or the absence thereof, alerting caregivers when a patient attempts to exit the bed or has not moved for a specified period, supporting fall prevention and patient safety. It is classified as FDA Class 1, indicating low risk subject to general controls with no premarket submission required. The product code is KMI and it is regulated under 21 CFR 880.2400 in the General Hospital specialty.

View on FDA

510(k)s

FEI Numbers

102

Registration Numbers

102

Unique Applicants

Years Active

Basic Information

Product Code: KMI
Device Class: FDA class 1
Regulation Number: 880.2400
Medical Specialty: General Hospital
Review Panel: HO
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 31 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K141877	LEAF PATIENT MONITORING SYSTEM	Nov 10, 2014	Substantially Equivalent	Leaf Healthcare, Inc.
K131585	INTEL-GE CARE INNOVATIONS QUIETCARE	Oct 08, 2013	Substantially Equivalent	Intel-Ge Care Innovations, LLC
K130752	DYNASENSE SYSTEM	Aug 15, 2013	Substantially Equivalent	Centauri Medical, Inc.
K101109	VIVATRAK	Jul 15, 2010	Substantially Equivalent	Wireless Medcare, LLC
K090138	MOBILECARE MONITOR, MODEL 2100	Apr 24, 2009	Substantially Equivalent	Aframe Digital, Inc.
K942770	ULTIMAT-SENSOR FOR BED OCCUPANCY MONITOR	Dec 23, 1994	Substantially Equivalent	Ultimate Development Corp.
K943481	INFORMER PLUS	Nov 02, 1994	Substantially Equivalent	Micro-Tech Medical, Inc.
K933552	PM-PAGER	Sep 22, 1994	Substantially Equivalent	Hill Engineering
K934344	HOME AMB-ALERT	Apr 29, 1994	Substantially Equivalent	Medway
K940405	TELETOM	Apr 14, 1994	Substantially Equivalent	Berchtold Holding GmbH
K924433	SENIOR TECH TABS 88 TRANS RA1/WRA1/R1 ANN TYPE CR1	Jun 24, 1993	Substantially Equivalent	Senior Technologies, Inc.
K925529	WANDER CARE	Jun 16, 1993	Substantially Equivalent	Care Electronics, Inc.
K920206	POSEY SITTER	May 14, 1992	Substantially Equivalent	J. T. Posey Co.
K914859	BARTRONIX IN-BED ACTIVITY MONITOR	Apr 13, 1992	Substantially Equivalent	Bartronix
K911079	AMB-ALERT	Sep 13, 1991	Substantially Equivalent	Medway
K905586	RSVP RF-2000	Apr 01, 1991	Substantially Equivalent	Tactilitics, Inc.
K905421	EXIT ALARM	Feb 12, 1991	Substantially Equivalent	Alertcare
K901969	ALERT BED ALARM SYSTEM	Sep 12, 1990	Substantially Equivalent	Alertronics, Inc.
K901330	THE MONITOR ELECTRONIC BED ALARM SYSTEM	Aug 30, 1990	Substantially Equivalent	The Monitor Corp.
K883390	PMD SYSTEM-20	Oct 25, 1988	Substantially Equivalent	Datatek, Inc.
K873806	JDM SP2 SENSOR	Dec 08, 1987	Substantially Equivalent	Jd Monitoring C/O Mackler, Cooper and Gibbs
K872358	STA-PUT	Aug 06, 1987	Substantially Equivalent	Design Technologies, Inc.
K871203	BED PATIENT PRESENCE MONITOR	May 26, 1987	Substantially Equivalent	Human Technologies, Inc.
K864827	RSVP SYSTEMS, SERIES I, BED-PATIENT MONITOR	Jan 21, 1987	Substantially Equivalent	Tactilitics, Inc.
K860537	THE CELL CARE SYSTEM	Apr 17, 1986	Substantially Equivalent	The Clell Corp.
K854950	BED PATIENT MONITOR	Mar 25, 1986	Substantially Equivalent	Clearview Electronics Corp.
K841672	FALL-SAFE VEST	Jul 03, 1984	Substantially Equivalent	Fsm Corp.
K841671	FALL-SAFE MONITOR	Jul 03, 1984	Substantially Equivalent	Fsm Corp.
K840295	AMBULARM	May 07, 1984	Substantially Equivalent	Rigi Systems, Inc.
K823926	BED-CHECK: II-IFAC	Apr 18, 1983	Substantially Equivalent	Bed-Check Corp.
K770695	MONITOR, BED, TECHNOLICS	Jul 14, 1977	Substantially Equivalent	Technolics, Inc.