Cleared Traditional

K900783 - MDI ADAPTOR

K900783 is an FDA 510(k) clearance for MDI ADAPTOR, manufactured by Hudson Oxygen Therapy Sales Co.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K900783 · Hudson Oxygen Therapy Sales Co. · Anesthesiology device
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Jul 1990
Decision
148d
Days
Class 2
Risk

K900783 is an FDA 510(k) clearance for the MDI ADAPTOR. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Hudson Oxygen Therapy Sales Co. (Temecula, US). The FDA issued a Cleared decision on July 18, 1990 after a review of 148 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 - K900783

510(k) Number K900783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1990
Decision Date July 18, 1990
Days to Decision 148 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 140d · This submission: 148d
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 466
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K900783.
AEROMIST II NEBULIZER
K901315 · Inhalation Plastics · Sep 1990
TRACH CARE MDI ADAPTER
K900273 · Ballard Medical Products · Aug 1990
PHARMATRONICS NEBULIZER
K896536 · Diversatronics, Inc. · Jul 1990
ACCESSORY FITMENT TO NEBULIZER SYSTEM, STERILE
K901362 · Automatic Liquid Packaging, Inc. · Jun 1990
STER INHAL SOLUT PREFIL BTL W/ADJUST ENTRAIN NEBUL
K901301 · Automatic Liquid Packaging, Inc. · May 1990
MEDISONIC HUMDIFIER/INHALER
K901114 · Medisonic U.S.A., Inc. · May 1990
K900783 · MDI ADAPTOR
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