Cleared Traditional

K903580 - MICRO-MISTER

K903580 is an FDA 510(k) clearance for MICRO-MISTER, manufactured by Bp , Ltd.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K903580 · Bp , Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1990
Decision
141d
Days
Class 2
Risk

K903580 is an FDA 510(k) clearance for the MICRO-MISTER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Bp , Ltd. (Middletown, US). The FDA issued a Cleared decision on December 27, 1990 after a review of 141 days - within the typical 510(k) review window.

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 - K903580

510(k) Number K903580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1990
Decision Date December 27, 1990
Days to Decision 141 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 140d · This submission: 141d
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 459
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K903580.
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
AEROMIST II NEBULIZER
K901315 · Inhalation Plastics · Sep 1990
TRACH CARE MDI ADAPTER
K900273 · Ballard Medical Products · Aug 1990
K903580 · MICRO-MISTER
Download PDF Bp , Ltd.