Cleared Traditional

K113549 - COMFORT COUGH

K113549 is an FDA 510(k) clearance for COMFORT COUGH, manufactured by Seoil Pacific Corp.. The device is a Class 2 Anesthesiology device with product code NHJ cleared through the Traditional 510(k) pathway after a 448-day FDA review.

K113549 · Seoil Pacific Corp. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
448d
Days
Class 2
Risk

K113549 is an FDA 510(k) clearance for the COMFORT COUGH. Classified as Device, Positive Pressure Breathing, Intermittent (product code NHJ), Class II - Special Controls.

Submitted by Seoil Pacific Corp. (Seoul, KR). The FDA issued a Cleared decision on February 21, 2013 after a review of 448 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

FDA 510(k) Submission Details - K113549

510(k) Number K113549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2011
Decision Date February 21, 2013
Days to Decision 448 days
Submission Type Traditional
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
308d slower than avg
Panel avg: 140d · This submission: 448d
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 22
Devices cleared under the same product code (NHJ) and FDA review panel - the closest regulatory comparables to K113549.
MINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG PERC
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K072292 · Dima Italia Srl · Jan 2008