510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K831768Substantially Equivalent

External Pulse Generator for Temp. Stim

Oscor Inc., Palm Harbor FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831768 is the FDA 510(k) clearance record for EXTERNAL PULSE GENERATOR FOR TEMP. STIM, a class II device, cleared for Oscor, Inc. on under FDA product code DTE (Pulse-Generator, Pacemaker, External). FDA records list 49 510(k) clearances for Oscor, Inc., from to . As of , FDA records show no recalls naming K831768.

Clearance record

Decision date
Received
(198 days to decision)
Product code
DTE Pulse-Generator, Pacemaker, External
Regulation
21 CFR 870.3600
Device class
Class II
Review panel
Cardiovascular
Applicant
Oscor, Inc. 3816 Desoto Blvd., Palm Harbor FL
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