Cleared Traditional

K760674 - SYN-O-SCOPE NASAL INHALER

K760674 is an FDA 510(k) clearance for SYN-O-SCOPE NASAL INHALER, manufactured by Mcdonald and Assoc., Inc.. The device is a Class 1 Ear, Nose, Throat device with product code KCO cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K760674 · Mcdonald and Assoc., Inc. · Ear, Nose, Throat device
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Mar 1977
Decision
175d
Days
Class 1
Risk

K760674 is an FDA 510(k) clearance for the SYN-O-SCOPE NASAL INHALER. Classified as Nasal Spray, Ent Delivery (product code KCO), Class I - General Controls.

Submitted by Mcdonald and Assoc., Inc. (Mchenry, US). The FDA issued a Cleared decision on March 10, 1977 after a review of 175 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.5220 - 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 Mcdonald and Assoc., Inc. devices

FDA 510(k) Submission Details - K760674

510(k) Number K760674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1976
Decision Date March 10, 1977
Days to Decision 175 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
86d slower than avg
Panel avg: 89d · This submission: 175d
Pathway characteristics
Predicate-based equivalence.

KCO Device Classification - Class 1, General Controls

Product Code KCO Nasal Spray, Ent Delivery
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.5220
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.