Cleared Traditional

Portable Mesh Nebulizer (K182906) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K182906 · Feellife Health, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2020
Decision
711d
Days
Class 2
Risk

K182906 is an FDA 510(k) clearance for the Portable Mesh Nebulizer. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Feellife Health, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on September 27, 2020 after a review of 711 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Feellife Health, Inc. devices

Submission Details

510(k) Number K182906 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2018
Decision Date September 27, 2020
Days to Decision 711 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
571d slower than avg
Panel avg: 140d · This submission: 711d
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 Consultant

Medwheat (Shanghai) Medical Technology Co. , Ltd.
Jonathan Hu

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - CAF Nebulizer (direct Patient Interface)

All 73
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K182906.
Ultrasonic Mesh Nebulizer
K201397 · Shenzhen Ivankaca Technology Co., Ltd. · Jun 2021
Corrugated tube with mouthpiece accessory
K203400 · Trudell Medical International · Jun 2021
AireHealth NebulizerTM
K201167 · Airehealth, Inc. · Dec 2020
AeroEclipse* ONE BAN
K200063 · Trudell Medical International · Jul 2020
GUS831 Compressor Nebulizer
K192633 · Globalcare Medical Technology Co., Ltd. · May 2020
Propeller Sensor for Symbicort
K192724 · Reciprocal Labs Corporation · Mar 2020