Cleared Traditional

K895913 - STANDARD NEBULIZER HEATER

K895913 is an FDA 510(k) clearance for STANDARD NEBULIZER HEATER, manufactured by Seamless Div., Professional Medical Products. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K895913 · Seamless Div., Professional Medical Products · Anesthesiology device
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Dec 1989
Decision
73d
Days
Class 2
Risk

K895913 is an FDA 510(k) clearance for the STANDARD NEBULIZER HEATER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Seamless Div., Professional Medical Products (Ocala, US). The FDA issued a Cleared decision on December 22, 1989 after a review of 73 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 - K895913

510(k) Number K895913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1989
Decision Date December 22, 1989
Days to Decision 73 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
67d faster than avg
Panel avg: 140d · This submission: 73d
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 458
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K895913.
PARI I.S.-2
K896984 · Dura Pharmaceuticals, Inc. · Mar 1990
(HEART) NEBULIZER
K896696 · Vortran Medical Technology 1, Inc. · Feb 1990
MEDISONIC PNEU-NEB
K896192 · Medisonic U.S.A., Inc. · Jan 1990
MEDISONIC ULTRA-SONIC INHALER
K894961 · Medisonic U.S.A., Inc. · Nov 1989
CATALOG NO. 1755 1S0-NEB, A FILTERED NEBULIZER
K895231 · Hudson Oxygen Therapy Sales Co. · Oct 1989
MEDIPART DISPOSABLE AEROSOL SYSTEM MP-070-PTD
K894138 · Medipart Jerry Alexander · Sep 1989
K895913 · STANDARD NEBULIZER HEATER
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