Cleared Traditional

K896375 - PREEMICARE NEBUTECH NEBULIZER SYSTEM

K896375 is the FDA 510(k) clearance for PREEMICARE NEBUTECH NEBULIZER SYSTEM by Preemicare Corp.. It is a Class 2 Anesthesiology device (product code CAF) cleared through the Traditional 510(k) pathway after a 357-day FDA review.

K896375 · Preemicare Corp. · Anesthesiology device
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Oct 1990
Decision
357d
Days
Class 2
Risk

K896375 is an FDA 510(k) clearance for the PREEMICARE NEBUTECH NEBULIZER SYSTEM. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Preemicare Corp. (Houston, US). The FDA issued a Cleared decision on October 29, 1990 after a review of 357 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Preemicare Corp. devices

Submission Details

510(k) Number K896375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1989
Decision Date October 29, 1990
Days to Decision 357 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
217d slower than avg
Panel avg: 140d · This submission: 357d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 94
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K896375.
MISTY OX TURBOHEATER
K962438 · Vital Signs, Inc. · Jan 1997
BAXTER NEBULIZER CAP MODEL 2D0868
K962161 · Baxter Healthcare Corp · Aug 1996
COMPANION 800 PORTABLE NEBULIZER COMPRESSOR (C800)
K921809 · Puritan Bennett Corp. · Dec 1992
OMRON ULTRASONIC NEBULIZER NE-U06
K875134 · Nidek, Inc. · Dec 1988
AIRLIFE MISTY NEB MEDICATION SYSTEM W/FILTER
K883964 · Baxter Healthcare Corp · Nov 1988
NEBULAIRE (IRC 1040) NEBULIZER PUMP
K851436 · Invacare Corp. · Jul 1985