Cleared Traditional

K800023 - LUNG AEROSOL UNIT

K800023 is an FDA 510(k) clearance for LUNG AEROSOL UNIT, manufactured by Cadema Medical Products, Inc.. The device is a Class 2 General Hospital device with product code CAF cleared through the Traditional 510(k) pathway after a 1821-day FDA review.

K800023 · Cadema Medical Products, Inc. · General Hospital
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Jan 1985
Decision
1821d
Days
Class 2
Risk

K800023 is an FDA 510(k) clearance for the LUNG AEROSOL UNIT. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Cadema Medical Products, Inc. (Walker, US). The FDA issued a Cleared decision on January 1, 1985 after a review of 1821 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 868.5630 - the FDA general hospital 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Cadema Medical Products, Inc. devices

FDA 510(k) Submission Details - K800023

510(k) Number K800023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1980
Decision Date January 01, 1985
Days to Decision 1821 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1692d slower than avg
Panel avg: 129d · This submission: 1821d
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 General Hospital 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 K800023.
SERVO NEBULIZER 945 SIEMENS-ELEMA AB
K871293 · Siemens Elema AB · May 1987
NEBULAIRE (IRC 1040) NEBULIZER PUMP
K851436 · Invacare Corp. · Jul 1985
VARIABLE NEBULIZER HEATER
K851074 · Travenol Laboratories, S.A. · Jun 1985
SINGLE USE NEBULIZER-ADJUST-AIR ENTRAIN
K834077 · Airlife, Inc. · Dec 1983
NEBULIZER ACCESSORY FOR SERVO VENTILL
K832898 · Siemens Elema AB · Nov 1983
DISPOS. MEDICATION NEBULIZER
K831270 · Hospitak, Inc. · Jun 1983