Cleared Traditional

K140598 - PEGASO COUGH

K140598 is an FDA 510(k) clearance for PEGASO COUGH, manufactured by Dima Italia Srl. The device is a Class 2 Anesthesiology device with product code NHJ cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K140598 · Dima Italia Srl · Anesthesiology device
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Oct 2014
Decision
220d
Days
Class 2
Risk

K140598 is an FDA 510(k) clearance for the PEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERC. Classified as Device, Positive Pressure Breathing, Intermittent (product code NHJ), Class II - Special Controls.

Submitted by Dima Italia Srl (Bologna, IT). The FDA issued a Cleared decision on October 16, 2014 after a review of 220 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - 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 Dima Italia Srl devices

FDA 510(k) Submission Details - K140598

510(k) Number K140598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2014
Decision Date October 16, 2014
Days to Decision 220 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 140d · This submission: 220d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 12
Devices cleared under the same product code (NHJ) and FDA review panel - the closest regulatory comparables to K140598.
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K121955 · Respironics, Inc. · Dec 2012
PERCUSSIVENEB, MODEL PN-2001
K003684 · Vortran Medical Technology 1, Inc. · Feb 2001
EMERSON COUGH ASSIST MODEL CA-3000 W/AUTOMATIC TIMING AND MODEL CM-3000 W/MANUAL TIMING
K002598 · J. H. Emerson Co. · Nov 2000