Cleared Traditional

K911192 - DP 100

K911192 is the FDA 510(k) clearance for DP 100 by Ferguson Medical. It is a Class 2 Anesthesiology device (product code CAF) cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K911192 · Ferguson Medical · Anesthesiology device
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Dec 1991
Decision
268d
Days
Class 2
Risk

K911192 is an FDA 510(k) clearance for the DP 100. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Ferguson Medical (Chico, US). The FDA issued a Cleared decision on December 11, 1991 after a review of 268 days - an extended review 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: 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 Ferguson Medical devices

Submission Details

510(k) Number K911192 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 18, 1991
Decision Date December 11, 1991
Days to Decision 268 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
128d slower than avg
Panel avg: 140d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 161
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K911192.
NE-U07
K922923 · Omron Healthcare, Inc. · Sep 1992
NE-U04/NE U04F
K923024 · Omron Healthcare, Inc. · Sep 1992
OMRON COMPRESSOR NEBULIZER- MODEL NE-C09
K914836 · Omron Healthcare, Inc. · May 1992
DEVILBISS MODEL 7427D
K913316 · Devilbiss Health Care, Inc. · Dec 1991
RHINO-GUARD
K911785 · Micromedics, Inc. · Oct 1991
DEVILBISS MODEL 5000
K911896 · Devilbiss Health Care, Inc. · Jul 1991