510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K901332Substantially Equivalent

Pk-55 Andover Medical Part #5455 Label Change

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

K901332 is the FDA 510(k) clearance record for PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE, a class II device, cleared for Biotronik, GmbH & Co. on under FDA product code DTC (Analyzer, Pacemaker Generator Function). FDA records list 104 510(k) clearances for Biotronik, GmbH & Co., from to . As of , FDA records show no recalls naming K901332.

Clearance record

Decision date
Received
(48 days to decision)
Product code
DTC Analyzer, Pacemaker Generator Function
Regulation
21 CFR 870.3630
Device class
Class II
Review panel
Cardiovascular
Applicant
Biotronik, GmbH & Co. 6024 Southwest Jean Rd., Lake Oswego OR
Third party review
No

Clearances, product code DTC

Trailing 12 months

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

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