Cleared Traditional

Intelligent Mesh Nebulizer (K171549) - FDA 510(k) Clearance

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

K171549 · Qingdao Future Medical Technology Co., Ltd. · Anesthesiology device
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Aug 2018
Decision
462d
Days
Class 2
Risk

K171549 is an FDA 510(k) clearance for the Intelligent Mesh Nebulizer. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Qingdao Future Medical Technology Co., Ltd. (Qingdao, CN). The FDA issued a Cleared decision on August 31, 2018 after a review of 462 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 Qingdao Future Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K171549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2017
Decision Date August 31, 2018
Days to Decision 462 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
322d slower than avg
Panel avg: 140d · This submission: 462d
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

Beijing Believe Technology Service Co., Ltd.
Ray Wang

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 71
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K171549.
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K170886 · Shenzhen Homed Medical Device Co., Ltd. · Jun 2018