Cleared Traditional

TBI TRAINER (K840837) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K840837 · Manico · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1985
Decision
395d
Days
Class 1
Risk

K840837 is an FDA 510(k) clearance for the TBI TRAINER. Classified as Attachment, Binocular, For Endoscope (product code FEJ), Class I - General Controls.

Submitted by Manico (Walker, US). The FDA issued a Cleared decision on March 25, 1985 after a review of 395 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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. Elevated predicate reliance profile. 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 Manico devices

Submission Details

510(k) Number K840837 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1984
Decision Date March 25, 1985
Days to Decision 395 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
265d slower than avg
Panel avg: 130d · This submission: 395d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FEJ Attachment, Binocular, For Endoscope
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.1500
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.