510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K171514Substantially Equivalent

BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set

BIOTRONIK AG, Lake Oswego OR / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K171514 is the FDA 510(k) clearance record for BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set, a class II device, cleared for Biotronik, Inc. on under FDA product code MXD (Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)). FDA records list 104 510(k) clearances for Biotronik, Inc., from to . As of , FDA records show no recalls naming K171514.

Clearance record

Decision date
Received
(36 days to decision)
Product code
MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Regulation
21 CFR 870.1025
Device class
Class II
Review panel
Cardiovascular
Applicant
Biotronik, Inc. 6024 Jean Rd., Lake Oswego OR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MXD

Trailing 12 months
3 clearances under product code MXD in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MXD, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20261
September 20260
October 20260