Cleared Traditional

K030396 - OMNI~NEB

Also marketed or referenced as:
OMNI~MAX

K030396 is an FDA 510(k) clearance for OMNI~NEB, manufactured by B&B Medical Technologies, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 456-day FDA review.

K030396 · B&B Medical Technologies, Inc. · Anesthesiology device
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May 2004
Decision
456d
Days
Class 2
Risk

K030396 is an FDA 510(k) clearance for the OMNI~NEB. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by B&B Medical Technologies, Inc. (North Highlands, US). The FDA issued a Cleared decision on May 7, 2004 after a review of 456 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 B&B Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K030396

510(k) Number K030396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2003
Decision Date May 07, 2004
Days to Decision 456 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
316d slower than avg
Panel avg: 140d · This submission: 456d
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 223
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