Cleared Traditional

K142516 - Propeller System

K142516 is the FDA 510(k) clearance for Propeller System by Reciprocal Labs Corporation. It is a Class 2 Anesthesiology device (product code CAF) cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K142516 · Reciprocal Labs Corporation · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
249d
Days
Class 2
Risk

K142516 is an FDA 510(k) clearance for the Propeller System. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Reciprocal Labs Corporation (Madison, US). The FDA issued a Cleared decision on May 15, 2015 after a review of 249 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 Reciprocal Labs Corporation devices

Submission Details

510(k) Number K142516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2014
Decision Date May 15, 2015
Days to Decision 249 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
109d slower than avg
Panel avg: 140d · This submission: 249d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 135
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K142516.
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
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