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) Official FDA 510(k) Summary (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.

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 472
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K970035.
OPTIVENT
K963793 · Health Care Products, Inc. · Apr 1997
COMPRESSOR/NEBULIZER #3650
K970289 · Devilbiss Health Care, Inc. · Apr 1997
FPT NEBULIZER
K970010 · Fluid Propulsion Technologies, Inc. · Apr 1997
THE SWIRLER NEBULIZER
K952910 · Amici, Inc. · Mar 1997
THERA-MIST NEBULIZER MODEL-P3000
K962534 · Pegasus Research Corp. · Feb 1997
RESPIFLO
K962872 · Tyco Healthcare Deutschaland GmbH · Feb 1997
K970035 · JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009
Download PDF FDA Summary Graham-Field, Inc.