Cleared Traditional

VERSION OF A CLOSED-FLOW SYS. CALORIC (K813490) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K813490 · Thomas M. Foti, M.D. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1982
Decision
34d
Days
Class 1
Risk

K813490 is an FDA 510(k) clearance for the VERSION OF A CLOSED-FLOW SYS. CALORIC. Classified as Unit, Examining/treatment, Ent (product code ETF), Class I - General Controls.

Submitted by Thomas M. Foti, M.D. (Mchenry, US). The FDA issued a Cleared decision on January 7, 1982 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.5300 - the FDA ear, nose and throat 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 Thomas M. Foti, M.D. devices

Submission Details

510(k) Number K813490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1981
Decision Date January 07, 1982
Days to Decision 34 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 89d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ETF Unit, Examining/treatment, Ent
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.5300
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.