FDA product code KMI: Monitor, Bed Patient
KMI is the FDA product code for monitor, bed patient. It is a Class I device, regulated under 21 CFR 880.2400 and reviewed by the General Hospital panel. FDA has cleared 31 510(k) submissions under KMI, from 28 different applicants. The average 510(k) review took 130 days (median 106). FDA has posted 32 recalls for KMI devices.
Classification
| Field | Value |
|---|---|
| Device name | Monitor, Bed Patient |
| Device class | Class I |
| Regulation | 21 CFR 880.2400 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KMI clearance
Top KMI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medway | 2 | 1994-04-29 |
| Tactilitics, Inc. | 2 | 1991-04-01 |
| Fsm Corp. | 2 | 1984-07-03 |
| Leaf Healthcare, Inc. | 1 | 2014-11-10 |
| Intel-Ge Care Innovations, LLC | 1 | 2013-10-08 |
23 more applicants have KMI clearances. See the full list in Caduvo.
Most recent KMI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K141877 | Leaf Healthcare, Inc. | LEAF PATIENT MONITORING SYSTEM | 2014-11-10 | 122 |
| K131585 | Intel-Ge Care Innovations, LLC | INTEL-GE CARE INNOVATIONS QUIETCARE | 2013-10-08 | 130 |
| K130752 | Centauri Medical, Inc. | DYNASENSE SYSTEM | 2013-08-15 | 149 |
| K101109 | Wireless Medcare, LLC | VIVATRAK | 2010-07-15 | 86 |
| K090138 | Aframe Digital, Inc. | MOBILECARE MONITOR, MODEL 2100 | 2009-04-24 | 93 |
Recalls for KMI devices
32 product recalls in 16 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-02-14.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2020 | 1 |
Frequently asked questions
What is FDA product code KMI?
KMI is the FDA product code for monitor, bed patient. It is a Class I device, regulated under 21 CFR 880.2400 and reviewed by the General Hospital panel.
What device class is KMI?
Class I, regulation 21 CFR 880.2400. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KMI?
Across 31 cleared submissions the average was 130 days from receipt to decision (median 106).
Which companies have the most KMI clearances?
Medway (2); Tactilitics, Inc. (2); Fsm Corp. (2); Leaf Healthcare, Inc. (1); Intel-Ge Care Innovations, LLC (1).
Have KMI devices been recalled?
Yes: 32 product recalls across 16 recall events; the most recent began 2020-02-14.
Next steps
- Run an FDA pathway report with predicate devices for product code KMI
- Run a recall and safety report across every KMI manufacturer
- Watch product code KMI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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