Cleared Traditional

K011601 - ARDO SUCTION PUMP MASTER, MODEL 30.00.XX

Also marketed or referenced as:
ARDO SUCTION PUMP SENATOR, MODEL 31.00.XX

K011601 is an FDA 510(k) clearance for ARDO SUCTION PUMP MASTER, manufactured by Ardo Medical AG. The device is a Class 2 General & Plastic Surgery device with product code BTA cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K011601 · Ardo Medical AG · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
15d
Days
Class 2
Risk

K011601 is an FDA 510(k) clearance for the ARDO SUCTION PUMP MASTER, MODEL 30.00.XX. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Ardo Medical AG (Unterageri, CH). The FDA issued a Cleared decision on June 8, 2001 after a review of 15 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 Ardo Medical AG devices

FDA 510(k) Submission Details - K011601

510(k) Number K011601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2001
Decision Date June 08, 2001
Days to Decision 15 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 115d · This submission: 15d
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 Consultant

Tuv Product Service, Inc.
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - BTA Pump, Portable, Aspiration (manual Or Powered)

All 110
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K011601.
MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057
K021368 · Medela AG · May 2002
MEDIPORT 2000 MOBILE
K013585 · Servox Medizintechnik GmbH · Jan 2002
DURQ/ QUALIDURA
K013116 · Ever-Safety Technical Service · Jan 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

FDA 510(k) Resources - General & Plastic Surgery

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.