Cleared Traditional

K972778 - DEY VIAL SODIUM CHLORIDE 3%

K972778 is an FDA 510(k) clearance for DEY VIAL SODIUM CHLORIDE 3%, manufactured by Dey Laboratories, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K972778 · Dey Laboratories, Inc. · Anesthesiology device
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Oct 1997
Decision
75d
Days
Class 2
Risk

K972778 is an FDA 510(k) clearance for the DEY VIAL SODIUM CHLORIDE 3%. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Dey Laboratories, Inc. (Napa, US). The FDA issued a Cleared decision on October 8, 1997 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5630 - the FDA anesthesiology and respiratory 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 Dey Laboratories, Inc. devices

FDA 510(k) Submission Details - K972778

510(k) Number K972778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1997
Decision Date October 08, 1997
Days to Decision 75 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 140d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAF Device Classification - Class 2, Special Controls

Product Code CAF Nebulizer (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5630
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CAF Nebulizer (direct Patient Interface)

All 247
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K972778.
0.9.% SODIUM CHLORIDE INHALATION SOLUTION, USP
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MODEL IRC 1199 SCOUT NEBULIZER
K973468 · Invacare Corp. · Dec 1997
ATOMISOR
K970844 · Medical Consulting Service, Inc. · Nov 1997
SPACE CHAMBER FOR MODEL NUMBER AND ACCESSORIES
K971808 · Monarch Medical · Sep 1997
SODIUM CHLORIDE INHALATION SOLUTION, USP
K972466 · Holopack International, LP · Aug 1997
STERILE WATER FOR INHALATION, USP
K972467 · Holopack International, LP · Aug 1997