Cleared Traditional

K904718 - AERO-GEN NUBULIZER SYSTEM

K904718 is an FDA 510(k) clearance for AERO-GEN NUBULIZER SYSTEM, manufactured by Tri/Bor Medical, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K904718 · Tri/Bor Medical, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1991
Decision
165d
Days
Class 2
Risk

K904718 is an FDA 510(k) clearance for the AERO-GEN NUBULIZER SYSTEM. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Tri/Bor Medical, Inc. (Westtown, US). The FDA issued a Cleared decision on April 1, 1991 after a review of 165 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K904718

510(k) Number K904718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1990
Decision Date April 01, 1991
Days to Decision 165 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 140d · This submission: 165d
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 457
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K904718.
HEART NEBULIZER POLE CLAMP
K913000 · B&B Medical Technologies, Inc. · Aug 1991
DEVILBISS MODEL 5000
K911896 · Devilbiss Health Care, Inc. · Jul 1991
WATER COLUMN RELIEF VALVE
K904398 · Icn Pharmaceuticals, Inc. · Jul 1991
MINI-MICRON CIRCUIT
K903499 · Medical Industries America, Inc. · Mar 1991
PREEMICARE NEBUTECH NEBULIZER SYSTEM
K896375 · Preemicare Corp. · Oct 1990
TRACH CARE MDI ADAPTER
K900273 · Ballard Medical Products · Aug 1990
K904718 · AERO-GEN NUBULIZER SYSTEM
Download PDF Tri/Bor Medical, Inc.