Product code KMI— General Hospital
ALERT BED ALARM SYSTEM
- Classification name
- Monitor, Bed Patient
- Device class
- Class 1
- Regulation
- 21 CFR 880.2400
- Advisory panel
- General Hospital
- Total cleared
- 31
- First cleared
- Most recent
Market context for product code KMI
FDA has cleared devices under product code KMI between 1977 and 2014, filed by 28 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
last 15 years- 2014
- 2013
- 2010
- 2009
- 1994
- 1993
- 1992
- 1991
- 1990
- 1988
- 1987
- 1986
- 1984
- 1983
- 1977
Top applicants under product code KMI
Recent clearances under product code KMI
- K141877 — LEAF PATIENT MONITORING SYSTEM
- K131585 — INTEL-GE CARE INNOVATIONS QUIETCARE
- K130752 — DYNASENSE SYSTEM
- K101109 — VIVATRAK
- K090138 — MOBILECARE MONITOR, MODEL 2100
- K942770 — ULTIMAT-SENSOR FOR BED OCCUPANCY MONITOR
- K943481 — INFORMER PLUS
- K933552 — PM-PAGER
- K934344 — HOME AMB-ALERT
- K940405 — TELETOM
- K924433 — SENIOR TECH TABS 88 TRANS RA1/WRA1/R1 ANN TYPE CR1
- K925529 — WANDER CARE
- K920206 — POSEY SITTER
- K914859 — BARTRONIX IN-BED ACTIVITY MONITOR
- K911079 — AMB-ALERT
- K905586 — RSVP RF-2000
- K905421 — EXIT ALARM
- K901969 — ALERT BED ALARM SYSTEM
- K901330 — THE MONITOR ELECTRONIC BED ALARM SYSTEM
- K883390 — PMD SYSTEM-20
- K873806 — JDM SP2 SENSOR
- K872358 — STA-PUT
- K871203 — BED PATIENT PRESENCE MONITOR
- K864827 — RSVP SYSTEMS, SERIES I, BED-PATIENT MONITOR
- K860537 — THE CELL CARE SYSTEM
- K854950 — BED PATIENT MONITOR
- K841671 — FALL-SAFE MONITOR
- K841672 — FALL-SAFE VEST
- K840295 — AMBULARM
- K823926 — BED-CHECK: II-IFAC
- K770695 — MONITOR, BED, TECHNOLICS
Data sourced from openFDA. This site is unofficial and independent of the FDA.