510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K882327Substantially Equivalent

Pacer Sensing Analyzer (Psa 100)

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

K882327 is the FDA 510(k) clearance record for PACER SENSING ANALYZER (PSA 100), a class II device, cleared for Oscor Medical Corp. on under FDA product code DTC (Analyzer, Pacemaker Generator Function). FDA records list 31 510(k) clearances for Oscor Medical Corp., from to . As of , FDA records show no recalls naming K882327.

Clearance record

Decision date
Received
(122 days to decision)
Product code
DTC Analyzer, Pacemaker Generator Function
Regulation
21 CFR 870.3630
Device class
Class II
Review panel
Cardiovascular
Applicant
Oscor Medical Corp. 3816 Desoto Blvd., Palm Harbor FL
Third party review
No

Clearances, product code DTC

Trailing 12 months

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

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