Cleared Traditional

K130001 - CARE SU01A SUCTION ASPIRATOR

K130001 is an FDA 510(k) clearance for CARE SU01A SUCTION ASPIRATOR, manufactured by Foshan Care Medical Technology Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code JCX cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K130001 · Foshan Care Medical Technology Co., Ltd. · General & Plastic Surgery device
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Jul 2013
Decision
204d
Days
Class 2
Risk

K130001 is an FDA 510(k) clearance for the CARE SU01A SUCTION ASPIRATOR. Classified as Apparatus, Suction, Ward Use, Portable, Ac-powered (product code JCX), Class II - Special Controls.

Submitted by Foshan Care Medical Technology Co., Ltd. (Foshan, Guangdong, CN). The FDA issued a Cleared decision on July 25, 2013 after a review of 204 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4780 - the FDA general and plastic surgery 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 General & Plastic Surgery 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 - K130001

510(k) Number K130001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2013
Decision Date July 25, 2013
Days to Decision 204 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 115d · This submission: 204d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

JCX Device Classification - Class 2, Special Controls

Product Code JCX Apparatus, Suction, Ward Use, Portable, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4780
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - JCX Apparatus, Suction, Ward Use, Portable, Ac-powered

All 29
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