Cleared Traditional

K850778 - SET -502T PH ESOPHAGEAL MICRO SIZE ELEC...

K850778 is an FDA 510(k) clearance for SET -502T PH ESOPHAGEAL MICRO SIZE ELEC..., manufactured by Settler Medical Electronics, Inc.. The device is a Class 1 Gastroenterology & Urology device with product code FFT cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K850778 · Settler Medical Electronics, Inc. · Gastroenterology & Urology device
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Jun 1985
Decision
107d
Days
Class 1
Risk

K850778 is an FDA 510(k) clearance for the SET -502T PH ESOPHAGEAL MICRO SIZE ELECTRODE. Classified as Electrode, Ph, Stomach (product code FFT), Class I - General Controls.

Submitted by Settler Medical Electronics, Inc. (Winnipeg, CA). The FDA issued a Cleared decision on June 13, 1985 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1400 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Settler Medical Electronics, Inc. devices

FDA 510(k) Submission Details - K850778

510(k) Number K850778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1985
Decision Date June 13, 1985
Days to Decision 107 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 130d · This submission: 107d
Pathway characteristics
Predicate-based equivalence.

FFT Device Classification - Class 1, General Controls

Product Code FFT Electrode, Ph, Stomach
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.1400
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FFT Electrode, Ph, Stomach

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