510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K864318Substantially Equivalent

The Buddy System/health Information System

The Buddy Systems, Inc., Northbrook IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864318 is the FDA 510(k) clearance record for THE BUDDY SYSTEM/HEALTH INFORMATION SYSTEM, a class II device, cleared for The Buddy Systems, Inc. on under FDA product code DXN (System, Measurement, Blood-Pressure, Non-Invasive). FDA records list 2 510(k) clearances for The Buddy Systems, Inc., from to . As of , FDA records show no recalls naming K864318.

Clearance record

Decision date
Received
(137 days to decision)
Product code
DXN System, Measurement, Blood-Pressure, Non-Invasive
Regulation
21 CFR 870.1130
Device class
Class II
Review panel
Cardiovascular
Applicant
The Buddy Systems, Inc. 1880 Holste Rd., Northbrook IL
Third party review
No

Clearances, product code DXN

Trailing 12 months
30 clearances under product code DXN in the twelve months to October 2026, April 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code DXN, trailing twelve months
MonthClearances
November 20250
December 20251
January 20262
February 20264
March 20262
April 20265
May 20263
June 20264
July 20262
August 20264
September 20262
October 20261