Cleared Traditional

K970035 - JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009

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

K970035 · Graham-Field, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K970035

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
Combination Product No
PCCP Authorized No
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.

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 247
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K970035.
MASTER NEB II
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COMPRESSOR/NEBULIZER #3650
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FPT NEBULIZER
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K964994 · Contemporary Products, Inc. · Feb 1997
MISTY OX TURBOHEATER
K962438 · Vital Signs, Inc. · Jan 1997
3050 SPORT-NEB
K964078 · Medical Industries America, Inc. · Jan 1997