510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K062331Substantially Equivalent

Highpak-12

Ad Elektronik GmbH, Lutsen MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K062331 is the FDA 510(k) clearance record for HIGHPAK-12, a class II device, cleared for Ad Elektronik GmbH on under FDA product code MPD (Auxiliary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator). FDA records list 2 510(k) clearances for Ad Elektronik GmbH, from to . As of , FDA records show no recalls naming K062331.

Clearance record

Decision date
Received
(334 days to decision)
Product code
MPD Auxiliary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator
Regulation
21 CFR 870.5300
Device class
Class II
Review panel
Cardiovascular
Applicant
Ad Elektronik GmbH 3924 Cascade Beach Rd., Lutsen MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MPD

Trailing 12 months

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

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