Cleared Abbreviated

K052650 - PIONEER U601 SERIES ASPIRATOR (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K052650 · Merits Health Products Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
75d faster than avg
Panel avg: 114d · This submission: 39d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 154
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K052650.
Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)
K253107 · Shenzhen Dongjiang Technology Co., Ltd. · Apr 2026
Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)
K260147 · Shenzhen Kingboom Technology Co., Ltd. · Mar 2026
Baby Nasal Aspirator (BN002)
K251450 · Shenzhen Desida Technology Co., Ltd. · Jun 2025
Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610)
K244033 · Shenzhen Desida Technology Co., Ltd. · May 2025
AIRO Suction Unit (AIRO-01)
K251101 · Cro, LLC · Apr 2025
Electric Nasal Aspirator (BC026, BC025, BC023)
K250697 · Shenzhen Kingboom Technology Co., Ltd. · Apr 2025