Cleared Traditional

K113033 - SODIUM CHLORDE INHALATION SOLUTION

K113033 is an FDA 510(k) clearance for SODIUM CHLORDE INHALATION SOLUTION, manufactured by Nephron Pharmaceuticals Corp.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 251-day FDA review.

K113033 · Nephron Pharmaceuticals Corp. · Anesthesiology device
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Jun 2012
Decision
251d
Days
Class 2
Risk

K113033 is an FDA 510(k) clearance for the SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Nephron Pharmaceuticals Corp. (Orlando, US). The FDA issued a Cleared decision on June 19, 2012 after a review of 251 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 Nephron Pharmaceuticals Corp. devices

FDA 510(k) Submission Details - K113033

510(k) Number K113033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2011
Decision Date June 19, 2012
Days to Decision 251 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
111d slower than avg
Panel avg: 140d · This submission: 251d
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 224
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K113033.
CLEVER TD-7001NEBULIZER
K122060 · Taidoc Technology Corporation · Mar 2013
ULTRASONIC NEBULIZER (MESH TYPE)
K121520 · K-Jump Health Co., Ltd. · Mar 2013
U-RIGHT COMPRESSOR NEBULIZER
K121969 · Taidoc Technology Corporation · Feb 2013
COMP A-I-R
K110860 · Omron Healthcare, Inc. · Sep 2011
RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V
K101857 · Instrumentation Industries, Inc. · Jul 2010
MERITS MODEL N SERIES NEBULIZER COMPRESSORS
K092859 · Merits Health Products Co., Ltd. · Jul 2010