510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K083828Substantially Equivalent

Sleuth at Implantable Cardiac Monitoring System -6 Cm and 8Cm Antenna, Personal Diagnostics Manager (Pdm) Accessory Kit

Transoma, St. Paul MN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083828 is the FDA 510(k) clearance record for SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM -6 CM AND 8CM ANTENNA, PERSONAL DIAGNOSTICS MANAGER (PDM) ACCESSORY KIT, a class II device, cleared for Transoma on under FDA product code MXC (Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)). FDA records list one 510(k) clearance for Transoma. As of , FDA records show no recalls naming K083828.

Clearance record

Decision date
Received
(50 days to decision)
Product code
MXC Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
Regulation
21 CFR 870.2800
Device class
Class II
Review panel
Cardiovascular
Applicant
Transoma 119 14th St. NW, St. Paul MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MXC

Trailing 12 months

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

FDA records show no clearances under product code MXC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MXC, 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