510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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KMIClass I

Monitor, Bed Patient

21 CFR 880.2400 / General Hospital
FDA source (opens on fda.gov)

KMI is the FDA product code for Monitor, Bed Patient, a class I device type, regulated under 21 CFR 880.2400. As of , FDA records hold 31 510(k) clearances under this code, the most recent dated , and 32 recalls.

Classification record

Product code
KMI
Device name
Monitor, Bed Patient
Regulation
21 CFR 880.2400
Device class
Class I
Review panel
General Hospital
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
31
Ingested recalls
32

Clearances, product code KMI

By decision year
31 clearances under product code KMI with a decision year between 1977 and 2014, 1994 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code KMI by decision year
YearClearances
19771
19831
19843
19862
19874
19881
19902
19913
19922
19932
19945
20091
20101
20132
20141

Applicants with the most clearances

Product code KMI
Applicants holding the most 510(k) clearances under product code KMI
ApplicantClearances
Medway2
Tactilitics, Inc.2
Aframe Digital, Inc.1
Alertcare1
Alertronics, Inc.1
Bartronix1
Bed-Check Corp.1
Berchtold Holding GmbH1
Care Electronics, Inc.1
Centauri Medical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 94 companies shown, in name order