Cleared Traditional

K161586 - The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) (FDA 510(k) Clearance)

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

K161586 · Shenzhen Homed Medical Device Co., Ltd. · Anesthesiology device
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Sep 2017
Decision
455d
Days
Class 2
Risk

K161586 is an FDA 510(k) clearance for the The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-23.... Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Shenzhen Homed Medical Device Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on September 6, 2017 after a review of 455 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 Shenzhen Homed Medical Device Co., Ltd. devices

Submission Details

510(k) Number K161586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2016
Decision Date September 06, 2017
Days to Decision 455 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
316d slower than avg
Panel avg: 139d · This submission: 455d
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)

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