Cleared Traditional

K970035 - JOHN BUNN NEB-U-LITE II MEDICATION COMP...

K970035 is the FDA 510(k) clearance for JOHN BUNN NEB-U-LITE II MEDICATION COMP... by Graham-Field, Inc.. It is a Class 2 Anesthesiology device (product code CAF) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K970035 · Graham-Field, Inc. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Apr 1997
Decision
88d
Days
Class 2
Risk

K970035 is an FDA 510(k) clearance for the JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODE.... Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Graham-Field, Inc. (Great Neck,, US). The FDA issued a Cleared decision on April 1, 1997 after a review of 88 days - a notably fast clearance cycle.

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: 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 Graham-Field, Inc. devices

Submission Details

510(k) Number K970035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1997
Decision Date April 01, 1997
Days to Decision 88 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 140d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 94
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