Cleared Traditional

RINOFLOW MICRONIZED E.N..T. WASH SYTSTEM (K963550) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K963550 · Respironics, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
57d
Days
Class 1
Risk

K963550 is an FDA 510(k) clearance for the RINOFLOW MICRONIZED E.N..T. WASH SYTSTEM. 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 November 1, 1996 after a review of 57 days - a notably fast clearance cycle.

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: 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 Respironics, Inc. devices

Submission Details

510(k) Number K963550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1996
Decision Date November 01, 1996
Days to Decision 57 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
32d faster than avg
Panel avg: 89d · This submission: 57d
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.