Cleared Traditional

K142153 - HUDSON RCI ADDIPAK UNIT DOSE VIAL

Also marketed or referenced as:
5ML 15ML

K142153 is an FDA 510(k) clearance for HUDSON RCI ADDIPAK UNIT DOSE VIAL, 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 266-day FDA review.

K142153 · Teleflexmedical, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
266d
Days
Class 2
Risk

K142153 is an FDA 510(k) clearance for the HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE SOLUTION, 3ML. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Teleflexmedical, Inc. (Durham, US). The FDA issued a Cleared decision on April 29, 2015 after a review of 266 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 - K142153

510(k) Number K142153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2014
Decision Date April 29, 2015
Days to Decision 266 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
126d slower than avg
Panel avg: 140d · This submission: 266d
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 K142153.
AirLife Misty Finity Nebulizer
K153748 · Care Fusion · May 2017
RTC 26-C Inline Aerosol Adapter
K162753 · Instrumentation Industries, Inc. · Feb 2017
Hudson RCI AquaPak Sterile Prefilled Nebulizers
K153010 · Teleflexmedical, Inc. · Jul 2016
AQUAPAK NEBULIZER ADAPTORS/RESERVOIRS
K141214 · Teleflexmedical, Inc. · Dec 2014
COMP A-I-R
K141140 · Omron Healthcare, Inc. · Sep 2014
AIRLIFE
K123527 · Care Fusion · Apr 2013