Cleared Traditional

K180770 - Propeller Sensor for Neohaler

K180770 is the FDA 510(k) clearance for Propeller Sensor for Neohaler by Reciprocal Labs Corporation. It is a Class 2 Anesthesiology device (product code CAF) cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K180770 · Reciprocal Labs Corporation · Anesthesiology device
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Aug 2018
Decision
131d
Days
Class 2
Risk

K180770 is an FDA 510(k) clearance for the Propeller Sensor for Neohaler. 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 August 1, 2018 after a review of 131 days - within the typical 510(k) review window.

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 K180770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2018
Decision Date August 01, 2018
Days to Decision 131 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
9d faster than avg
Panel avg: 140d · This submission: 131d
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 134
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K180770.
Hailie Sensor
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Portable Nebulizer
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Intelligent Mesh Nebulizer
K171549 · Qingdao Future Medical Technology Co., Ltd. · Aug 2018
Smartinhaler
K180407 · Adherium (Nz), Ltd. · Jul 2018
HOMED Mesh Nebulizer
K170886 · Shenzhen Homed Medical Device Co., Ltd. · Jun 2018
MC 300R* Nebulizer
K173825 · Trudell Medical International · May 2018