510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K934344Substantially Equivalent

Home Amb-Alert

Medway, Franklin TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K934344 is the FDA 510(k) clearance record for HOME AMB-ALERT, a class I device, cleared for Medway on under FDA product code KMI (Monitor, Bed Patient). FDA records list 5 510(k) clearances for Medway, from to . As of , FDA records show no recalls naming K934344.

Clearance record

Decision date
Received
(233 days to decision)
Product code
KMI Monitor, Bed Patient
Regulation
21 CFR 880.2400
Device class
Class I
Review panel
General Hospital
Applicant
Medway 2176 Hillsboro Rd., Franklin TN
510(k) summary
Statement
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