Cleared Abbreviated

K052650 - PIONEER U601 SERIES ASPIRATOR

K052650 is an FDA 510(k) clearance for PIONEER U601 SERIES ASPIRATOR, manufactured by Merits Health Products Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code BTA cleared through the Abbreviated 510(k) pathway after a 39-day FDA review.

K052650 · Merits Health Products Co., Ltd. · General & Plastic Surgery device
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Nov 2005
Decision
39d
Days
Class 2
Risk

K052650 is an FDA 510(k) clearance for the PIONEER U601 SERIES ASPIRATOR. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Merits Health Products Co., Ltd. (Taichung, TW). The FDA issued a Cleared decision on November 4, 2005 after a review of 39 days - a notably fast clearance 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Merits Health Products Co., Ltd. devices

FDA 510(k) Submission Details - K052650

510(k) Number K052650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2005
Decision Date November 04, 2005
Days to Decision 39 days
Submission Type Abbreviated
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 115d · This submission: 39d
Pathway characteristics
Standards-based clearance path.

BTA Device Classification - Class 2, Special Controls

Product Code BTA Pump, Portable, Aspiration (manual Or 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 - BTA Pump, Portable, Aspiration (manual Or Powered)

All 69
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K043544 · Medela AG · Jan 2005