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
K033130Substantially Equivalent

Pace 101/Pace 101H, Model 3077 Ssi Temporary Pulse Generator

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

K033130 is the FDA 510(k) clearance record for PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR, 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 K033130.

Clearance record

Decision date
Received
(31 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. 7855 Ivanhoe Ave., Suite 226, 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