Cleared Traditional

K013116 - DURQ/ QUALIDURA

K013116 is an FDA 510(k) clearance for DURQ/ QUALIDURA, manufactured by Ever-Safety Technical Service. The device is a Class 2 General & Plastic Surgery device with product code BTA cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K013116 · Ever-Safety Technical Service · General & Plastic Surgery device
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Jan 2002
Decision
122d
Days
Class 2
Risk

K013116 is an FDA 510(k) clearance for the DURQ/ QUALIDURA. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Ever-Safety Technical Service (Taichung Hsien, Taiwan, CN). The FDA issued a Cleared decision on January 18, 2002 after a review of 122 days - within the typical 510(k) review window.

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 Ever-Safety Technical Service devices

FDA 510(k) Submission Details - K013116

510(k) Number K013116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2001
Decision Date January 18, 2002
Days to Decision 122 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 115d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 96
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K013116.
MEDELA DOMINANT 35 C/I SECRETION AND SURGICAL ASPIRATOR
K043544 · Medela AG · Jan 2005
MEDELA CLARIO HOME CARE PUMP
K033179 · Medela AG · Oct 2003
MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057
K021368 · Medela AG · May 2002
LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20
K993668 · Laerdal Medical A/S · Dec 1999
SORING GMBH, SONOCA 300
K992026 · Soring GmbH Medizintechnik · Sep 1999
XPS TISSUE ASPIRATION SYSTEM, XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM
K984363 · Xomed, Inc. · Feb 1999