Cleared Traditional

K071607 - ASA01 HEAVY DUTY SUCTION PUMP

K071607 is an FDA 510(k) clearance for ASA01 HEAVY DUTY SUCTION PUMP, manufactured by Zhongshan A&J Medical Equipment Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code BTA cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K071607 · Zhongshan A&J Medical Equipment Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
14d
Days
Class 2
Risk

K071607 is an FDA 510(k) clearance for the ASA01 HEAVY DUTY SUCTION PUMP. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Zhongshan A&J Medical Equipment Co., Ltd. (Guangdong, CN). The FDA issued a Cleared decision on June 26, 2007 after a review of 14 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Zhongshan A&J Medical Equipment Co., Ltd. devices

FDA 510(k) Submission Details - K071607

510(k) Number K071607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2007
Decision Date June 26, 2007
Days to Decision 14 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
101d faster than avg
Panel avg: 115d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 100
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K071607.
AVITA NASAL ASPIRATOR, MODEL, NS1 SERIES
K090379 · Avita Corporation · May 2010
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MEDELA THOPAZ, MODEL 200 0288
K080212 · Medela AG · Jul 2008
SMARTSUCTION SOLO DEVICE
K062801 · Haemonetics Corp. · Oct 2006
MEDELA VARIO 8/18/CI SECRETION & SURGICAL ASPIRATOR
K061205 · Medela AG · Jun 2006
PIONEER U601 SERIES ASPIRATOR
K052650 · Merits Health Products Co., Ltd. · Nov 2005