Cleared Traditional

K900470 - IN-THE NEBULIZER

K900470 is an FDA 510(k) clearance for IN-THE NEBULIZER, 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 107-day FDA review.

K900470 · Hudson Oxygen Therapy Sales Co. · Anesthesiology device
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May 1990
Decision
107d
Days
Class 2
Risk

K900470 is an FDA 510(k) clearance for the IN-THE NEBULIZER. 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 May 18, 1990 after a review of 107 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.

View all Hudson Oxygen Therapy Sales Co. devices

FDA 510(k) Submission Details - K900470

510(k) Number K900470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1990
Decision Date May 18, 1990
Days to Decision 107 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
33d faster than avg
Panel avg: 140d · This submission: 107d
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 245
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K900470.
MDI ADAPTOR
K900783 · Hudson Oxygen Therapy Sales Co. · 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
H.E.A.R.T. NEBULIZER
K900228 · B&B Medical Technologies, Inc. · Mar 1990
INTERTECH/INSPIRON (R) MEDICATION NEBULIZER KIT
K896923 · Intertech Resources, Inc. · Mar 1990
(HEART) NEBULIZER
K896696 · Vortran Medical Technology 1, Inc. · Feb 1990