Atlas FDA

KMI

31 FDA 510(k) clearances · Product code

106 daysmedian time to decision
226 days90th percentile
31clearances measured

FDA profile

Official device name
Monitor, Bed Patient
Device class
Class I (low risk)
Regulation
21 CFR 880.2400
Medical specialty
General Hospital
Adverse events (MAUDE)
2021: 14 · 2022: 21 · 2023: 35 · 2024: 69 · 2025: 84 · 2026: 71
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
LEAF PATIENT MONITORING SYSTEM (K141877)Leaf Healthcare, Inc.2014-11-10
INTEL-GE CARE INNOVATIONS QUIETCARE (K131585)Intel-Ge Care Innovations, LLC2013-10-08
DYNASENSE SYSTEM (K130752)Centauri Medical, Inc.2013-08-15
VIVATRAK (K101109)Wireless Medcare, LLC2010-07-15
MOBILECARE MONITOR, MODEL 2100 (K090138)Aframe Digital, Inc.2009-04-24
ULTIMAT-SENSOR FOR BED OCCUPANCY MONITOR (K942770)Ultimate Development Corp.1994-12-23
INFORMER PLUS (K943481)Micro-Tech Medical, Inc.1994-11-02
PM-PAGER (K933552)Hill Engineering1994-09-22
HOME AMB-ALERT (K934344)Medway1994-04-29
TELETOM (K940405)Berchtold Holding GmbH1994-04-14
SENIOR TECH TABS 88 TRANS RA1/WRA1/R1 ANN TYPE CR1 (K924433)Senior Technologies, Inc.1993-06-24
WANDER CARE (K925529)Care Electronics, Inc.1993-06-16
POSEY SITTER (K920206)J. T. Posey Co.1992-05-14
BARTRONIX IN-BED ACTIVITY MONITOR (K914859)Bartronix1992-04-13
AMB-ALERT (K911079)Medway1991-09-13
RSVP RF-2000 (K905586)Tactilitics, Inc.1991-04-01
EXIT ALARM (K905421)Alertcare1991-02-12
ALERT BED ALARM SYSTEM (K901969)Alertronics, Inc.1990-09-12
THE MONITOR ELECTRONIC BED ALARM SYSTEM (K901330)The Monitor Corp.1990-08-30
PMD SYSTEM-20 (K883390)Datatek, Inc.1988-10-25
JDM SP2 SENSOR (K873806)Jd Monitoring C/O Mackler, Cooper and Gibbs1987-12-08
STA-PUT (K872358)Design Technologies, Inc.1987-08-06
BED PATIENT PRESENCE MONITOR (K871203)Human Technologies, Inc.1987-05-26
RSVP SYSTEMS, SERIES I, BED-PATIENT MONITOR (K864827)Tactilitics, Inc.1987-01-21
THE CELL CARE SYSTEM (K860537)The Clell Corp.1986-04-17
BED PATIENT MONITOR (K854950)Clearview Electronics Corp.1986-03-25
FALL-SAFE VEST (K841672)Fsm Corp.1984-07-03
FALL-SAFE MONITOR (K841671)Fsm Corp.1984-07-03
AMBULARM (K840295)Rigi Systems, Inc.1984-05-07
BED-CHECK: II-IFAC (K823926)Bed-Check Corp.1983-04-18
MONITOR, BED, TECHNOLICS (K770695)Technolics, Inc.1977-07-14

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Every clearance here is in the API, with alerts when new ones post.