510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K914859Substantially Equivalent

Bartronix in-Bed Activity Monitor

Bartronix, Fort Worth TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K914859 is the FDA 510(k) clearance record for BARTRONIX IN-BED ACTIVITY MONITOR, a class I device, cleared for Bartronix on under FDA product code KMI (Monitor, Bed Patient). FDA records list one 510(k) clearance for Bartronix. As of , FDA records show no recalls naming K914859.

Clearance record

Decision date
Received
(167 days to decision)
Product code
KMI Monitor, Bed Patient
Regulation
21 CFR 880.2400
Device class
Class I
Review panel
General Hospital
Applicant
Bartronix 7304 Bristlecone Ct., Fort Worth TX
510(k) summary
Summary
Third party review
No

Clearances, product code KMI

Trailing 12 months

FDA records hold no clearances under product code KMI in the trailing twelve months.

FDA records show no clearances under product code KMI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KMI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260