Cleared Traditional

K896375 - PREEMICARE NEBUTECH NEBULIZER SYSTEM

K896375 is an FDA 510(k) clearance for PREEMICARE NEBUTECH NEBULIZER SYSTEM, manufactured by Preemicare Corp.. The device is a Class 2 Anesthesiology device with 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

FDA 510(k) Submission Details - K896375

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.

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 401
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K896375.
DEVILBISS MODEL 5000
K911896 · Devilbiss Health Care, Inc. · Jul 1991
WATER COLUMN RELIEF VALVE
K904398 · Icn Pharmaceuticals, Inc. · Jul 1991
MINI-MICRON CIRCUIT
K903499 · Medical Industries America, Inc. · Mar 1991
TRACH CARE MDI ADAPTER
K900273 · Ballard Medical Products · Aug 1990
MDI ADAPTOR
K900783 · Hudson Oxygen Therapy Sales Co. · Jul 1990
ACCESSORY FITMENT TO NEBULIZER SYSTEM, STERILE
K901362 · Automatic Liquid Packaging, Inc. · Jun 1990