Cleared Traditional

K140237 - DISPOSABLE NEBULIZER SET

K140237 is an FDA 510(k) clearance for DISPOSABLE NEBULIZER SET, manufactured by Suzhou Weikang Medical Apparatus Co., Ltd.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 343-day FDA review.

K140237 · Suzhou Weikang Medical Apparatus Co., Ltd. · Anesthesiology device
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Jan 2015
Decision
343d
Days
Class 2
Risk

K140237 is an FDA 510(k) clearance for the DISPOSABLE NEBULIZER SET. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Suzhou Weikang Medical Apparatus Co., Ltd. (Guangzhou, Guangdong, CN). The FDA issued a Cleared decision on January 8, 2015 after a review of 343 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Suzhou Weikang Medical Apparatus Co., Ltd. devices

FDA 510(k) Submission Details - K140237

510(k) Number K140237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2014
Decision Date January 08, 2015
Days to Decision 343 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
203d slower than avg
Panel avg: 140d · This submission: 343d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAF Device Classification - Class 2, Special Controls

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 224
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