Cleared Traditional

K913316 - DEVILBISS MODEL 7427D

K913316 is an FDA 510(k) clearance for DEVILBISS MODEL 7427D, manufactured by Devilbiss Health Care, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K913316 · Devilbiss Health Care, Inc. · Anesthesiology device
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Dec 1991
Decision
140d
Days
Class 2
Risk

K913316 is an FDA 510(k) clearance for the DEVILBISS MODEL 7427D. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Devilbiss Health Care, Inc. (Somerset, US). The FDA issued a Cleared decision on December 11, 1991 after a review of 140 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 Devilbiss Health Care, Inc. devices

FDA 510(k) Submission Details - K913316

510(k) Number K913316 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 24, 1991
Decision Date December 11, 1991
Days to Decision 140 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 140d · This submission: 140d
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 229
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K913316.
HEART NUBULIZER
K920332 · Vortran Medical Technology 1, Inc. · May 1992
OMRON COMPRESSOR NEBULIZER- MODEL NE-C09
K914836 · Omron Healthcare, Inc. · May 1992
DP 100
K911192 · Ferguson Medical · Dec 1991
HEART NEBULIZER FLOWMETER ADAPTOR
K913015 · B&B Medical Technologies, Inc. · Nov 1991
DRUG NEBULIZERS
K911422 · Intersurgical, Inc. · Oct 1991
RHINO-GUARD
K911785 · Micromedics, Inc. · Oct 1991