510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K021217Substantially Equivalent

Arox 53-Bp; Arox 60-Bp; Arox 45-Jbp; Arox 53-Jbp

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

K021217 is the FDA 510(k) clearance record for AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP, a class III device, cleared for Biotronik, Inc. on under FDA product code DTB (Permanent Pacemaker Electrode). FDA records list 104 510(k) clearances for Biotronik, Inc., from to . As of , FDA records show no recalls naming K021217.

Clearance record

Decision date
Received
(14 days to decision)
Product code
DTB Permanent Pacemaker Electrode
Regulation
21 CFR 870.3680
Device class
Class III
Review panel
Cardiovascular
Applicant
Biotronik, Inc. 6024 Jean Rd., Lake Oswego OR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DTB

Trailing 12 months

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

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