Cleared Traditional

K821481 - NASAL-THROAT SPRAY IRRIGATION INSTRUM.

K821481 is an FDA 510(k) clearance for NASAL-THROAT SPRAY IRRIGATION INSTRUM., manufactured by Ethicare Products. The device is a Class 1 Ear, Nose, Throat device with product code ETP cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K821481 · Ethicare Products · Ear, Nose, Throat device
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Jun 1982
Decision
27d
Days
Class 1
Risk

K821481 is an FDA 510(k) clearance for the NASAL-THROAT SPRAY IRRIGATION INSTRUM.. Classified as Stimulator, Caloric-water (product code ETP), Class I - General Controls.

Submitted by Ethicare Products (Walker, US). The FDA issued a Cleared decision on June 14, 1982 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1800 - 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 Ethicare Products devices

FDA 510(k) Submission Details - K821481

510(k) Number K821481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1982
Decision Date June 14, 1982
Days to Decision 27 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
62d faster than avg
Panel avg: 89d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

ETP Device Classification - Class 1, General Controls

Product Code ETP Stimulator, Caloric-water
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.1800
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.