Cleared Traditional

K180115 - TWBM Pump

K180115 is an FDA 510(k) clearance for TWBM Pump, manufactured by Taiwan Biomaterial 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 189-day FDA review.

K180115 · Taiwan Biomaterial Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
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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

FDA 510(k) Submission Details - K180115

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.

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 43
Devices cleared under the same product code (JCX) and FDA review panel - the closest regulatory comparables to K180115.
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DV-300 Aspirator
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IntelliCart System
K172481 · Dornoch Medical Systems · Sep 2017
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K161358 · Surgical Instrument Service and Savings, Inc. · Aug 2017