Cleared Traditional

K820952 - OPTI-MIST

K820952 is an FDA 510(k) clearance for OPTI-MIST, manufactured by Corpak Co.. The device is a Class 2 Anesthesiology device with 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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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K820952

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.

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 244
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K820952.
SINGLE USE NEBULIZER, ADJUST. AIR-
K830895 · Airlife, Inc. · Apr 1983
PREFILLED RESPIRATORY THERAPY VIAL
K830943 · Automatic Liquid Packaging, Inc. · Apr 1983
AIRLIFE NEBULIZER HEATER
K821129 · Airlife, Inc. · May 1982
NEBULIZER HEATER
K810217 · Corpak Co. · Mar 1981
PREFILLED NEBULIZER
K810218 · Corpak Co. · Mar 1981
MISTY NEBULIZER
K802477 · Airlife, Inc. · Oct 1980