Cleared Traditional

K112859 - ERAPID NEBULIZER SYSTEM

K112859 is an FDA 510(k) clearance for ERAPID NEBULIZER SYSTEM, manufactured by Pari Respiratory Equipment, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K112859 · Pari Respiratory Equipment, Inc. · Anesthesiology device
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May 2012
Decision
243d
Days
Class 2
Risk

K112859 is an FDA 510(k) clearance for the ERAPID NEBULIZER SYSTEM. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Pari Respiratory Equipment, Inc. (Midlothian, US). The FDA issued a Cleared decision on May 30, 2012 after a review of 243 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 Pari Respiratory Equipment, Inc. devices

FDA 510(k) Submission Details - K112859

510(k) Number K112859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2011
Decision Date May 30, 2012
Days to Decision 243 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
103d slower than avg
Panel avg: 140d · This submission: 243d
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 407
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K112859.
ASTHMAPOLIS SYSTEM
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K112824 · Quality Life Technologies Co;Ltd · Jun 2012
SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML
K113033 · Nephron Pharmaceuticals Corp. · Jun 2012
AERONEB PRO
K120939 · Aerogen, Ltd. · Apr 2012
SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML
K120051 · Nephron Pharmaceuticals Corp. · Apr 2012
KOO SMALL VOLUME NEBULIZER (SVN)
K112041 · Koo (Shanghai) Industries Co., Ltd. · Dec 2011