Cleared Traditional

K153010 - Hudson RCI AquaPak Sterile Prefilled Ne...

K153010 is an FDA 510(k) clearance for Hudson RCI AquaPak Sterile Prefilled Ne..., manufactured by Teleflexmedical, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 286-day FDA review.

K153010 · Teleflexmedical, Inc. · Anesthesiology device
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Jul 2016
Decision
286d
Days
Class 2
Risk

K153010 is an FDA 510(k) clearance for the Hudson RCI AquaPak Sterile Prefilled Nebulizers. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Teleflexmedical, Inc. (Morrisville, US). The FDA issued a Cleared decision on July 26, 2016 after a review of 286 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 Teleflexmedical, Inc. devices

FDA 510(k) Submission Details - K153010

510(k) Number K153010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2015
Decision Date July 26, 2016
Days to Decision 286 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
146d slower than avg
Panel avg: 140d · This submission: 286d
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 223
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K153010.
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K162753 · Instrumentation Industries, Inc. · Feb 2017
HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE SOLUTION, 3ML
K142153 · Teleflexmedical, Inc. · Apr 2015
AQUAPAK NEBULIZER ADAPTORS/RESERVOIRS
K141214 · Teleflexmedical, Inc. · Dec 2014
COMP A-I-R
K141140 · Omron Healthcare, Inc. · Sep 2014