Cleared Traditional

K161454 - Propeller Sensor Model 2015-E

K161454 is an FDA 510(k) clearance for Propeller Sensor Model 2015-E, manufactured by Reciprocal Labs Corporation. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K161454 · Reciprocal Labs Corporation · Anesthesiology device
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Nov 2016
Decision
159d
Days
Class 2
Risk

K161454 is an FDA 510(k) clearance for the Propeller Sensor Model 2015-E. 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 November 1, 2016 after a review of 159 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

FDA 510(k) Submission Details - K161454

510(k) Number K161454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2016
Decision Date November 01, 2016
Days to Decision 159 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
19d slower than avg
Panel avg: 140d · This submission: 159d
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 349
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K161454.
Airworks Nebulizer pe1200m
K162041 · Convexity Scientific, LLC · May 2017
Velox Nebulizer System
K162785 · Pari Respiratory Equipment, Inc. · Apr 2017
RTC 26-C Inline Aerosol Adapter
K162753 · Instrumentation Industries, Inc. · Feb 2017
Hudson RCI AquaPak Sterile Prefilled Nebulizers
K153010 · Teleflexmedical, Inc. · Jul 2016
Propeller System
K152882 · Reciprocal Labs · Mar 2016
Propeller Sensor Model 2014-R
K152482 · Reciprocal Labs · Mar 2016