Cleared Traditional

RINOFLOW MICRONIZED E.N.T. WASH SYSTEM (K973875) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K973875 · Respironics, Inc. · Ear, Nose, Throat device
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Jan 1998
Decision
108d
Days
Class 1
Risk

K973875 is an FDA 510(k) clearance for the RINOFLOW MICRONIZED E.N.T. WASH SYSTEM. Classified as Irrigator, Powered Nasal (product code KMA), Class I - General Controls.

Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on January 26, 1998 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.5550 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Respironics, Inc. devices

Submission Details

510(k) Number K973875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1997
Decision Date January 26, 1998
Days to Decision 108 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 89d · This submission: 108d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KMA Irrigator, Powered Nasal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.5550
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.