510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K802316Substantially Equivalent

Pds Thermal Dilution Cardiac Module(out)

General Electric Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K802316 is the FDA 510(k) clearance record for PDS THERMAL DILUTION CARDIAC MODULE(OUT), a class II device, cleared for General Electric Co. on under FDA product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function). FDA records list 256 510(k) clearances for General Electric Co., from to . As of , FDA records show no recalls naming K802316.

Clearance record

Decision date
Received
(64 days to decision)
Product code
DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Regulation
21 CFR 870.1435
Device class
Class II
Review panel
Cardiovascular
Applicant
General Electric Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DXG

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