Cleared Special

K002598 - EMERSON COUGH ASSIST MODEL CA-3000 W/AU...

K002598 is an FDA 510(k) clearance for EMERSON COUGH ASSIST MODEL CA-3000 W/AU..., manufactured by J. H. Emerson Co.. The device is a Class 2 Anesthesiology device with product code NHJ cleared through the Special 510(k) pathway after a 93-day FDA review.

K002598 · J. H. Emerson Co. · Anesthesiology device
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Nov 2000
Decision
93d
Days
Class 2
Risk

K002598 is an FDA 510(k) clearance for the EMERSON COUGH ASSIST MODEL CA-3000 W/AUTOMATIC TIMING AND MODEL CM-3000 W/MAN.... Classified as Device, Positive Pressure Breathing, Intermittent (product code NHJ), Class II - Special Controls.

Submitted by J. H. Emerson Co. (Cambridge, US). The FDA issued a Cleared decision on November 22, 2000 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all J. H. Emerson Co. devices

FDA 510(k) Submission Details - K002598

510(k) Number K002598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2000
Decision Date November 22, 2000
Days to Decision 93 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 140d · This submission: 93d
Pathway characteristics
Modification to existing cleared device.

NHJ Device Classification - Class 2, Special Controls

Product Code NHJ Device, Positive Pressure Breathing, Intermittent
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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 - NHJ Device, Positive Pressure Breathing, Intermittent

All 11
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