Cleared Traditional

K903499 - MINI-MICRON CIRCUIT

K903499 is an FDA 510(k) clearance for MINI-MICRON CIRCUIT, manufactured by Medical Industries America, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 236-day FDA review.

K903499 · Medical Industries America, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1991
Decision
236d
Days
Class 2
Risk

K903499 is an FDA 510(k) clearance for the MINI-MICRON CIRCUIT. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Medical Industries America, Inc. (Adel, US). The FDA issued a Cleared decision on March 27, 1991 after a review of 236 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.

View all Medical Industries America, Inc. devices

FDA 510(k) Submission Details - K903499

510(k) Number K903499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1990
Decision Date March 27, 1991
Days to Decision 236 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 140d · This submission: 236d
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 219
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K903499.
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
TRACH CARE MDI ADAPTER
K900273 · Ballard Medical Products · Aug 1990
MDI ADAPTOR
K900783 · Hudson Oxygen Therapy Sales Co. · Jul 1990
ACCESSORY FITMENT TO NEBULIZER SYSTEM, STERILE
K901362 · Automatic Liquid Packaging, Inc. · Jun 1990