510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K022939Substantially Equivalent

Oscor Pace 101/101H and Accessories, St.jude Medical Model 3077 and Accessories,cardiotronic Pace 101 and Accessories

Osypka Medical GmbH, La Jolla CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K022939 is the FDA 510(k) clearance record for OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES,CARDIOTRONIC PACE 101 AND ACCESSORIES, a class II device, cleared for Osypka Medical, Inc. on under FDA product code DTE (Pulse-Generator, Pacemaker, External). FDA records list 7 510(k) clearances for Osypka Medical, Inc., from to . As of , FDA records show no recalls naming K022939.

Clearance record

Decision date
Received
(29 days to decision)
Product code
DTE Pulse-Generator, Pacemaker, External
Regulation
21 CFR 870.3600
Device class
Class II
Review panel
Cardiovascular
Applicant
Osypka Medical, Inc. 7463 Draper Ave., La Jolla CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DTE

Trailing 12 months

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

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