Cleared Traditional

K913015 - HEART NEBULIZER FLOWMETER ADAPTOR

K913015 is an FDA 510(k) clearance for HEART NEBULIZER FLOWMETER ADAPTOR, 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 135-day FDA review.

K913015 · B&B Medical Technologies, Inc. · Anesthesiology device
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Nov 1991
Decision
135d
Days
Class 2
Risk

K913015 is an FDA 510(k) clearance for the HEART NEBULIZER FLOWMETER ADAPTOR. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by B&B Medical Technologies, Inc. (Orangevale, US). The FDA issued a Cleared decision on November 20, 1991 after a review of 135 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all B&B Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K913015

510(k) Number K913015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1991
Decision Date November 20, 1991
Days to Decision 135 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
5d faster than avg
Panel avg: 140d · This submission: 135d
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
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K913015.
OMRON COMPRESSOR NEBULIZER- MODEL NE-C09
K914836 · Omron Healthcare, Inc. · May 1992
DP 100
K911192 · Ferguson Medical · Dec 1991
DEVILBISS MODEL 7427D
K913316 · Devilbiss Health Care, Inc. · Dec 1991
RHINO-GUARD
K911785 · Micromedics, Inc. · Oct 1991
VORTRAN INTERMITTENT SIGNAL ACTIVATED NEBULIZER
K911759 · Vortran Medical Technology 1, Inc. · Sep 1991
HEART NEBULIZER POLE CLAMP
K913000 · B&B Medical Technologies, Inc. · Aug 1991