Cleared Traditional

K820952 - OPTI-MIST

K820952 is the FDA 510(k) clearance for OPTI-MIST by Corpak Co.. It is a Class 2 Anesthesiology device (product code CAF) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K820952 · Corpak Co. · Anesthesiology device

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Apr 1982

Decision

23d

Days

Class 2

Risk

K820952 is an FDA 510(k) clearance for the OPTI-MIST. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Corpak Co. (Mchenry, US). The FDA issued a Cleared decision on April 29, 1982 after a review of 23 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 Corpak Co. devices

Submission Details

510(k) Number	K820952 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 06, 1982
Decision Date	April 29, 1982
Days to Decision	23 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

117d faster than avg

Panel avg: 140d · This submission: 23d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

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 101

Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K820952.

SINGLE USE NEBULIZER-ADJUST-AIR ENTRAIN

K834077 · Airlife, Inc. · Dec 1983

SINGLE USE NEBULIZER, ADJUST. AIR-

K830895 · Airlife, Inc. · Apr 1983

AIRLIFE NEBULIZER HEATER

K821129 · Airlife, Inc. · May 1982

MISTY NEBULIZER

K802477 · Airlife, Inc. · Oct 1980

CIRCUITS, BREATHING W/CONNECTORS, ADAPT

K801875 · Airlife, Inc. · Aug 1980

0.45% SODIUM CHLORIDE SOL./RESP. THERAPY

K800294 · Abbott Laboratories · Mar 1980

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K820952

Corpak Co.

Mchenry, IL · US

Regulatory profile

21 submissions 20 cleared

95% clearance rate · Active in Anesthesiology

Data Intelligence Layer

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Sourced from FDA 510(k) public files . Updated monthly.

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