510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K022360Substantially Equivalent

Era 3000; Pa-2 Is-1 Adapter; Ek-4-N Pacemaker Test Cable; Era 3000 Charger; Era 3000 Battery (Type 2); Nk-11 Power Supp.

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

K022360 is the FDA 510(k) clearance record for ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 3000 CHARGER; ERA 3000 BATTERY (TYPE 2); NK-11 POWER SUPP., a class II device, cleared for Biotronik, Inc. on under FDA product code DTA (Tester, Pacemaker Electrode Function). FDA records list 104 510(k) clearances for Biotronik, Inc., from to . As of , FDA records show no recalls naming K022360.

Clearance record

Decision date
Received
(192 days to decision)
Product code
DTA Tester, Pacemaker Electrode Function
Regulation
21 CFR 870.3720
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 DTA

Trailing 12 months

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

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