Cleared Traditional

K781542 - HEATED NEBULIZER

K781542 is the FDA 510(k) clearance for HEATED NEBULIZER by Chemetron Medical Products, Inc.. It is a Class 2 Anesthesiology device (product code CAF) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K781542 · Chemetron Medical Products, Inc. · Anesthesiology device
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Oct 1978
Decision
32d
Days
Class 2
Risk

K781542 is an FDA 510(k) clearance for the HEATED NEBULIZER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Chemetron Medical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 10, 1978 after a review of 32 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 Chemetron Medical Products, Inc. devices

Submission Details

510(k) Number K781542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1978
Decision Date October 10, 1978
Days to Decision 32 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 140d · This submission: 32d
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 107
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K781542.
MANIFOLD, UNIVERSAL I.P.P.B
K790152 · Airlife, Inc. · Mar 1979
MANIFOLD, W/CORRUGATED TUBING
K790153 · Airlife, Inc. · Mar 1979
MANIFOLD, FOR DOUBLE SUPPLY
K790154 · Airlife, Inc. · Mar 1979
U-FLOAT VALVE 2D9023
K781467 · Travenol Laboratories, S.A. · Sep 1978
SOLUTIONS FOR RESPIRATORY THERAPY
K780668 · Travenol Laboratories, S.A. · Jun 1978
2C7153 NEBULIZER CAP
K780406 · Travenol Laboratories, S.A. · Apr 1978