Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart C — General Hospital and Personal Use Monitoring Devices](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices) → [21 CFR 880.2400](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/880.2400) → KMI — Monitor, Bed Patient # KMI · Monitor, Bed Patient _General Hospital · 21 CFR 880.2400 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/KMI ## Overview - **Product Code:** KMI - **Device Name:** Monitor, Bed Patient - **Regulation:** [21 CFR 880.2400](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/880.2400) - **Device Class:** 1 - **Review Panel:** [General Hospital](/submissions/HO) ## Identification A bed-patient monitor is a battery-powered device placed under a mattress and used to indicate by an alarm or other signal when a patient attempts to leave the bed. ## Classification Rationale Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9. ## Recent Cleared Devices (20 of 31) Showing 20 most recent of 31 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K141877](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/KMI/K141877.md) | LEAF PATIENT MONITORING SYSTEM | Leaf Healthcare, Inc. | Nov 10, 2014 | SESE | | [K131585](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/KMI/K131585.md) | INTEL-GE CARE INNOVATIONS QUIETCARE | Intel-Ge Care Innovations, LLC | Oct 8, 2013 | SESE | | [K130752](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/KMI/K130752.md) | DYNASENSE SYSTEM | Centauri Medical, Inc. | Aug 15, 2013 | SESE | | [K101109](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/KMI/K101109.md) | VIVATRAK | Wireless Medcare, LLC | Jul 15, 2010 | SESE | | [K090138](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/KMI/K090138.md) | MOBILECARE MONITOR, MODEL 2100 | Aframe Digital, Inc. | Apr 24, 2009 | SESE | | [K942770](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/KMI/K942770.md) | ULTIMAT-SENSOR FOR BED OCCUPANCY MONITOR | Ultimate Development Corp. | Dec 23, 1994 | SESE | | [K943481](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/KMI/K943481.md) | INFORMER PLUS | Micro-Tech Medical, Inc. | Nov 2, 1994 | SESE | | [K933552](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/KMI/K933552.md) | PM-PAGER | Hill Engineering | Sep 22, 1994 | SESE | | [K934344](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/KMI/K934344.md) | HOME AMB-ALERT | Medway | Apr 29, 1994 | SESE | | [K940405](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/KMI/K940405.md) | TELETOM | Berchtold Holding GmbH | Apr 14, 1994 | SESE | | [K924433](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/KMI/K924433.md) | SENIOR TECH TABS 88 TRANS RA1/WRA1/R1 ANN TYPE CR1 | Senior Technologies, Inc. | Jun 24, 1993 | SESE | | [K925529](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/KMI/K925529.md) | WANDER CARE | Care Electronics, Inc. | Jun 16, 1993 | SESE | | [K920206](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/KMI/K920206.md) | POSEY SITTER | J. T. Posey Co. | May 14, 1992 | SESE | | [K914859](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/KMI/K914859.md) | BARTRONIX IN-BED ACTIVITY MONITOR | Bartronix | Apr 13, 1992 | SESE | | [K911079](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/KMI/K911079.md) | AMB-ALERT | Medway | Sep 13, 1991 | SESE | | [K905586](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/KMI/K905586.md) | RSVP RF-2000 | Tactilitics, Inc. | Apr 1, 1991 | SESE | | [K905421](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/KMI/K905421.md) | EXIT ALARM | Alertcare | Feb 12, 1991 | SESE | | [K901969](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/KMI/K901969.md) | ALERT BED ALARM SYSTEM | Alertronics, Inc. | Sep 12, 1990 | SESE | | [K901330](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/KMI/K901330.md) | THE MONITOR ELECTRONIC BED ALARM SYSTEM | The Monitor Corp. | Aug 30, 1990 | SESE | | [K883390](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/KMI/K883390.md) | PMD SYSTEM-20 | Datatek, Inc. | Oct 25, 1988 | SESE | ## Top Applicants - Fsm Corp. — 2 clearances - Medway — 2 clearances - Tactilitics, Inc. — 2 clearances - Aframe Digital, Inc. — 1 clearance - Alertcare — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/KMI](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/KMI) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com