Cleared Traditional

K800562 - DISPOSABLE HAND HELD NEBULIZER

K800562 is the FDA 510(k) clearance for DISPOSABLE HAND HELD NEBULIZER by Intec Medical, Inc.. It is a Class 2 Anesthesiology device (product code CAF) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K800562 · Intec Medical, Inc. · Anesthesiology device
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Mar 1980
Decision
13d
Days
Class 2
Risk

K800562 is an FDA 510(k) clearance for the DISPOSABLE HAND HELD NEBULIZER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Intec Medical, Inc. (Blue Springs, US). The FDA issued a Cleared decision on March 25, 1980 after a review of 13 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 Intec Medical, Inc. devices

Submission Details

510(k) Number K800562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1980
Decision Date March 25, 1980
Days to Decision 13 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
127d faster than avg
Panel avg: 140d · This submission: 13d
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 K800562.
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
0.9% SODIUM CHLORIDE SOL./RESP. THERAPY
K800295 · Abbott Laboratories · Mar 1980
NEBULIZER TUBING SET
K800083 · Abbott Laboratories · Jan 1980