Cleared Traditional

K873930 - AEROSOL DELIVERY SYSTEM (AERO-TECH II)

K873930 is an FDA 510(k) clearance for AEROSOL DELIVERY SYSTEM (AERO-TECH II), manufactured by Cadema Medical Products, Inc.. The device is a Class 2 Radiology device with product code CAF cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K873930 · Cadema Medical Products, Inc. · Radiology device
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Dec 1987
Decision
73d
Days
Class 2
Risk

K873930 is an FDA 510(k) clearance for the AEROSOL DELIVERY SYSTEM (AERO-TECH II). Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Cadema Medical Products, Inc. (Middletown, US). The FDA issued a Cleared decision on December 7, 1987 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 868.5630 - the FDA radiology and imaging software oversight 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.

View all Cadema Medical Products, Inc. devices

FDA 510(k) Submission Details - K873930

510(k) Number K873930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1987
Decision Date December 07, 1987
Days to Decision 73 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 107d · 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 Radiology 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 K873930.
BRONCHODILATOR TEE - 9056 SERIES
K873521 · Boehringer Laboratories · Mar 1988
ASTHMAKIT
K874047 · Dhd Medical Products Div. Diemolding Corp. · Feb 1988
RESPIRGARD II NEBULIZER SYSTEM
K874395 · Marquest Medical Products, Inc. · Dec 1987
HOYER SOLVET
K873395 · Infrasonics Corp. · Oct 1987
SERVO NEBULIZER 945 SIEMENS-ELEMA AB
K871293 · Siemens Elema AB · May 1987
NEBULAIRE (IRC 1040) NEBULIZER PUMP
K851436 · Invacare Corp. · Jul 1985