Cleared Traditional

ARDO SUCTION PUMP MASTER, MODEL 30.00.XX (K011601) - FDA 510(k) Clearance

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

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

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 33
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K011601.
SOMAVAC Device
K180606 · Somavac Medical Solutions, Inc. · May 2018
Rex Medical Aspiration Pump
K173389 · Rex Medical, L.P. · Jan 2018
Aprima Smartesis Centesis Pump
K161002 · Cook Incorporated · Sep 2016
UIMAT PUMP
K953132 · KARL STORZ Endoscopy-America, Inc. · Aug 1995
SYSTEC 280 INTEGRATED SUCTION SYSTEM
K791349 · Stryker Corp. · Sep 1979