Cleared Traditional

K903413 - MICROSPACER TM

K903413 is an FDA 510(k) clearance for MICROSPACER TM, manufactured by Respiratory Delivery Systems, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K903413 · Respiratory Delivery Systems, Inc. · Anesthesiology device
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Oct 1990
Decision
71d
Days
Class 2
Risk

K903413 is an FDA 510(k) clearance for the MICROSPACER TM. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Respiratory Delivery Systems, Inc. (Lowell, US). The FDA issued a Cleared decision on October 9, 1990 after a review of 71 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.

FDA 510(k) Submission Details - K903413

510(k) Number K903413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1990
Decision Date October 09, 1990
Days to Decision 71 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 140d · This submission: 71d
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 443
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K903413.
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
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