Cleared Traditional

TWBM Pump (K180115) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K180115 · Taiwan Biomaterial Co., Ltd. · General & Plastic Surgery device
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Jul 2018
Decision
189d
Days
Class 2
Risk

K180115 is an FDA 510(k) clearance for the TWBM Pump. Classified as Apparatus, Suction, Ward Use, Portable, Ac-powered (product code JCX), Class II - Special Controls.

Submitted by Taiwan Biomaterial Co., Ltd. (Zhubei, TW). The FDA issued a Cleared decision on July 24, 2018 after a review of 189 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 Taiwan Biomaterial Co., Ltd. devices

Submission Details

510(k) Number K180115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2018
Decision Date July 24, 2018
Days to Decision 189 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 115d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

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