Cleared Traditional

TEXAS INTERFACE PRESSURE EVALUATOR-TIPE (K831800) - FDA 510(k) Clearance

Class I Physical Medicine device.

K831800 · Tee-Kay Applied Technology · Physical Medicine device
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Aug 1983
Decision
85d
Days
Class 1
Risk

K831800 is an FDA 510(k) clearance for the TEXAS INTERFACE PRESSURE EVALUATOR-TIPE. Classified as System, Pressure Measurement, Intermittent (product code JFC), Class I - General Controls.

Submitted by Tee-Kay Applied Technology (Mchenry, US). The FDA issued a Cleared decision on August 16, 1983 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.1600 - the FDA physical medicine 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Tee-Kay Applied Technology devices

Submission Details

510(k) Number K831800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1983
Decision Date August 16, 1983
Days to Decision 85 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 115d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JFC System, Pressure Measurement, Intermittent
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.1600
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.