510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K850778Substantially Equivalent

Set -502T Ph Esophageal Micro Size Electrode

Settler Medical Electronics, Inc., Winnipeg, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850778 is the FDA 510(k) clearance record for SET -502T PH ESOPHAGEAL MICRO SIZE ELECTRODE, a class I device, cleared for Settler Medical Electronics, Inc. on under FDA product code FFT (Electrode, Ph, Stomach). FDA records list one 510(k) clearance for Settler Medical Electronics, Inc. As of , FDA records show no recalls naming K850778.

Clearance record

Decision date
Received
(107 days to decision)
Product code
FFT Electrode, Ph, Stomach
Regulation
21 CFR 876.1400
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Settler Medical Electronics, Inc. 723 Queenston St., Winnipeg, CA
Third party review
No

Clearances, product code FFT

Trailing 12 months

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

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