Cleared Traditional

K875024 - DEY-PAK AND DEY-VIAL SODIUM CHLORIDE SOLUTION, USP

K875024 is an FDA 510(k) clearance for DEY-PAK AND DEY-VIAL SODIUM CHLORIDE SO..., manufactured by Dey Laboratories, Inc.. The device is a Class 1 Anesthesiology device with product code CCQ cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K875024 · Dey Laboratories, Inc. · Anesthesiology device
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Jan 1988
Decision
49d
Days
Class 1
Risk

K875024 is an FDA 510(k) clearance for the DEY-PAK AND DEY-VIAL SODIUM CHLORIDE SOLUTION, USP. Classified as Nebulizer, Medicinal, Non-ventilatory (atomizer) (product code CCQ), Class I - General Controls.

Submitted by Dey Laboratories, Inc. (Concord, US). The FDA issued a Cleared decision on January 22, 1988 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5640 - 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 - K875024

510(k) Number K875024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1987
Decision Date January 22, 1988
Days to Decision 49 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 140d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

CCQ Device Classification - Class 1, General Controls

Product Code CCQ Nebulizer, Medicinal, Non-ventilatory (atomizer)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5640
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.

Regulatory Peers - CCQ Nebulizer, Medicinal, Non-ventilatory (atomizer)

All 25
Devices cleared under the same product code (CCQ) and FDA review panel - the closest regulatory comparables to K875024.
FREEWAY NEBULIZER COMPRESSOR
K895592 · Lifecare Services, Inc. · Nov 1989
DEVILBISS MODEL 6610D
K894441 · Devilbiss Health Care, Inc. · Oct 1989
DEVILBISS MODEL 8500D AND 8500D-608
K894244 · Devilbiss Health Care, Inc. · Oct 1989
MONAGHAN AEROCHAMBER WITH MASK
K874513 · Monaghan Medical Corp. · Dec 1987
INTERMITTENT SIGNAL ACTUATED NEBULIZER (VISAN)
K873477 · Vortran Medical Technology 1, Inc. · Oct 1987
PREFILLED RESPIRATORY THERAPY VIALS
K870332 · Automatic Liquid Packaging, Inc. · Apr 1987