Cleared Traditional

K973468 - MODEL IRC 1199 SCOUT NEBULIZER

K973468 is an FDA 510(k) clearance for MODEL IRC 1199 SCOUT NEBULIZER, manufactured by Invacare Corp.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K973468 · Invacare Corp. · Anesthesiology device
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Dec 1997
Decision
87d
Days
Class 2
Risk

K973468 is an FDA 510(k) clearance for the MODEL IRC 1199 SCOUT NEBULIZER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Invacare Corp. (Elyria, US). The FDA issued a Cleared decision on December 8, 1997 after a review of 87 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 Invacare Corp. devices

FDA 510(k) Submission Details - K973468

510(k) Number K973468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1997
Decision Date December 08, 1997
Days to Decision 87 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
53d faster than avg
Panel avg: 140d · This submission: 87d
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 407
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K973468.
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ATOMISOR
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SPACE CHAMBER FOR MODEL NUMBER AND ACCESSORIES
K971808 · Monarch Medical · Sep 1997