Cleared Traditional

K182906 - Portable Mesh Nebulizer (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
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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
Regulatory Context
Review time vs. panel average
572d slower than avg
Panel avg: 139d · 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 Peers - CAF Nebulizer (direct Patient Interface)

All 506
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K182906.
eRapid with eTrack System
K251572 · Pari Respiratory Equipment, Inc. · Dec 2025
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K251659 · Qingdao Future Medical Technology Co., Ltd. · Nov 2025
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K244035 · Shenzhen Jermei Medical Device Technology Co., Ltd. · Sep 2025
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K243468 · Joytech Healthcare Co. , Ltd. · Jul 2025
HeroTracker Sense
K250022 · Voluntis · Jun 2025
AdheResp Smart Breath-actuated Mesh Nebulizer
K250583 · Hcmed Innovations Co., Ltd. · Jun 2025