510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K232261Substantially Equivalent

TME Temporary Myocardial Electrode

OSYPKA GmbH, Rheinfelden, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K232261 is the FDA 510(k) clearance record for TME Temporary Myocardial Electrode, a class II device, cleared for Osypka AG on under FDA product code LDF (Electrode, Pacemaker, Temporary). FDA records list one 510(k) clearance for Osypka AG. As of , FDA records show no recalls naming K232261.

Clearance record

Decision date
Received
(270 days to decision)
Product code
LDF Electrode, Pacemaker, Temporary
Regulation
21 CFR 870.3680
Device class
Class II
Review panel
Cardiovascular
Applicant
Osypka AG Earl-H.-Wood St. 1, Rheinfelden, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LDF

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