Cleared Traditional

K895231 - CATALOG NO. 1755 1S0-NEB, A FILTERED NEBULIZER

K895231 is an FDA 510(k) clearance for CATALOG NO. 1755 1S0-NEB, 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 66-day FDA review.

K895231 · Hudson Oxygen Therapy Sales Co. · Anesthesiology device
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Oct 1989
Decision
66d
Days
Class 2
Risk

K895231 is an FDA 510(k) clearance for the CATALOG NO. 1755 1S0-NEB, A FILTERED 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 October 27, 1989 after a review of 66 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 - K895231

510(k) Number K895231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1989
Decision Date October 27, 1989
Days to Decision 66 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
74d faster than avg
Panel avg: 140d · This submission: 66d
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 K895231.
MEDISONIC PNEU-NEB
K896192 · Medisonic U.S.A., Inc. · Jan 1990
STANDARD NEBULIZER HEATER
K895913 · Seamless Div., Professional Medical Products · Dec 1989
MEDISONIC ULTRA-SONIC INHALER
K894961 · Medisonic U.S.A., Inc. · Nov 1989
MEDIPART DISPOSABLE AEROSOL SYSTEM MP-070-PTD
K894138 · Medipart Jerry Alexander · Sep 1989
THERA-MIST(TM) NEBULIZER, MODEL 30000
K893942 · Pegasus Research Corp. · Aug 1989
AEROCHAMBER M.V.
K884803 · Monaghan Medical Corp. · Apr 1989
K895231 · CATALOG NO. 1755 1S0-NEB, A FILTERED NEBULIZER
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