Cleared Traditional

K914772 - MEDIX NEBULIZING SYSTEM CODE NO. 2000 AND 2001

K914772 is an FDA 510(k) clearance for MEDIX NEBULIZING SYSTEM CODE NO. 2000 A..., manufactured by Medix Corp.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 312-day FDA review.

K914772 · Medix Corp. · Anesthesiology device
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Jul 1992
Decision
312d
Days
Class 2
Risk

K914772 is an FDA 510(k) clearance for the MEDIX NEBULIZING SYSTEM CODE NO. 2000 AND 2001. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Medix Corp. (Le17 6db, England, GB). The FDA issued a Cleared decision on July 24, 1992 after a review of 312 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 Medix Corp. devices

FDA 510(k) Submission Details - K914772

510(k) Number K914772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1991
Decision Date July 24, 1992
Days to Decision 312 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
172d slower than avg
Panel avg: 140d · This submission: 312d
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 384
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K914772.
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MININEB
K920443 · Vortran Medical Technology 1, Inc. · Jul 1992
HEART NUBULIZER
K920332 · Vortran Medical Technology 1, Inc. · May 1992
OMRON COMPRESSOR NEBULIZER- MODEL NE-C09
K914836 · Omron Healthcare, Inc. · May 1992