510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K844252Substantially Equivalent

Model 9300 Trend Analyzing Bio-Monitor Sys

Medtronic, Inc., Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844252 is the FDA 510(k) clearance record for MODEL 9300 TREND ANALYZING BIO-MONITOR SYS, a class II device, cleared for Medtronic Vascular on under FDA product code DXN (System, Measurement, Blood-Pressure, Non-Invasive). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K844252.

Clearance record

Decision date
Received
(236 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
Medtronic Vascular 800 53rd Ave., NE, Minneapolis MN
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