Cleared Traditional

K943717 - MASTER-NEB NEBULIZER COMPRESSOR SYSTEM

K943717 is an FDA 510(k) clearance for MASTER-NEB NEBULIZER COMPRESSOR SYSTEM, manufactured by Howard K. Mann & Assoc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 407-day FDA review.

K943717 · Howard K. Mann & Assoc. · Anesthesiology device
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Sep 1995
Decision
407d
Days
Class 2
Risk

K943717 is an FDA 510(k) clearance for the MASTER-NEB NEBULIZER COMPRESSOR SYSTEM. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Howard K. Mann & Assoc. (Edison, US). The FDA issued a Cleared decision on September 12, 1995 after a review of 407 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: 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 Anesthesiology submissions.

View all Howard K. Mann & Assoc. devices

FDA 510(k) Submission Details - K943717

510(k) Number K943717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1994
Decision Date September 12, 1995
Days to Decision 407 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
267d slower than avg
Panel avg: 140d · This submission: 407d
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 406
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K943717.
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