Cleared Traditional

K101552 - FOSHAN CARE MEDICAL NEBULIZER MODEL KYW...

K101552 is an FDA 510(k) clearance for FOSHAN CARE MEDICAL NEBULIZER MODEL KYW..., manufactured by Foshan Care Medical Technology Co., Ltd.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 283-day FDA review.

K101552 · Foshan Care Medical Technology Co., Ltd. · Anesthesiology device
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Mar 2011
Decision
283d
Days
Class 2
Risk

K101552 is an FDA 510(k) clearance for the FOSHAN CARE MEDICAL NEBULIZER MODEL KYWH2001. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Foshan Care Medical Technology Co., Ltd. (Carmichael, US). The FDA issued a Cleared decision on March 14, 2011 after a review of 283 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 Foshan Care Medical Technology Co., Ltd. devices

FDA 510(k) Submission Details - K101552

510(k) Number K101552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2010
Decision Date March 14, 2011
Days to Decision 283 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
143d slower than avg
Panel avg: 140d · This submission: 283d
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 191
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