Cleared Traditional

K913000 - HEART NEBULIZER POLE CLAMP

K913000 is an FDA 510(k) clearance for HEART NEBULIZER POLE CLAMP, 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 25-day FDA review.

K913000 · B&B Medical Technologies, Inc. · Anesthesiology device
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Aug 1991
Decision
25d
Days
Class 2
Risk

K913000 is an FDA 510(k) clearance for the HEART NEBULIZER POLE CLAMP. 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 August 2, 1991 after a review of 25 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 B&B Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K913000

510(k) Number K913000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1991
Decision Date August 02, 1991
Days to Decision 25 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
115d faster than avg
Panel avg: 140d · This submission: 25d
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 K913000.
HEART NEBULIZER FLOWMETER ADAPTOR
K913015 · B&B Medical Technologies, Inc. · Nov 1991
RHINO-GUARD
K911785 · Micromedics, Inc. · Oct 1991
VORTRAN INTERMITTENT SIGNAL ACTIVATED NEBULIZER
K911759 · Vortran Medical Technology 1, Inc. · Sep 1991
DEVILBISS MODEL 5000
K911896 · Devilbiss Health Care, Inc. · Jul 1991
WATER COLUMN RELIEF VALVE
K904398 · Icn Pharmaceuticals, Inc. · Jul 1991
MINI-MICRON CIRCUIT
K903499 · Medical Industries America, Inc. · Mar 1991