Cleared Traditional

K243468 - Compressor Nebulizer (NB-1100) (FDA 510(k) Clearance)

Also includes:

Compressor Nebulizer (NB-1101) Compressor Nebulizer (NB-1102) Compressor Nebulizer (NB-1103)

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

K243468 · Joytech Healthcare Co. , Ltd. · Anesthesiology device

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Jul 2025

Decision

236d

Days

Class 2

Risk

K243468 is an FDA 510(k) clearance for the Compressor Nebulizer (NB-1100). Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Joytech Healthcare Co. , Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on July 2, 2025 after a review of 236 days - an extended review cycle.

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 Joytech Healthcare Co. , Ltd. devices

Submission Details

510(k) Number	K243468 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 08, 2024
Decision Date	July 02, 2025
Days to Decision	236 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

97d slower than avg

Panel avg: 139d · This submission: 236d

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

Chonconn Consulting Co., Ltd.

Jie Yang

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.