Cleared Abbreviated

K111730 - SONOTT FLOWLAB(R)

K111730 is an FDA 510(k) clearance for SONOTT FLOWLAB, manufactured by Em-Tec GmbH. The device is a Class 2 Radiology device with product code DPW cleared through the Abbreviated 510(k) pathway after a 200-day FDA review.

K111730 · Em-Tec GmbH · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2012
Decision
200d
Days
Class 2
Risk

K111730 is an FDA 510(k) clearance for the SONOTT FLOWLAB(R). Classified as Flowmeter, Blood, Cardiovascular (product code DPW), Class II - Special Controls.

Submitted by Em-Tec GmbH (Finning, Bavaria, DE). The FDA issued a Cleared decision on January 6, 2012 after a review of 200 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 870.2100 - the FDA radiology and imaging software oversight 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.

FDA 510(k) Submission Details - K111730

510(k) Number K111730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2011
Decision Date January 06, 2012
Days to Decision 200 days
Submission Type Abbreviated
Review Panel Radiology (RA)
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
93d slower than avg
Panel avg: 107d · This submission: 200d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

DPW Device Classification - Class 2, Special Controls

Product Code DPW Flowmeter, Blood, Cardiovascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2100
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 Radiology devices follow this clearance model.

Regulatory Consultant

Tuv Sud America, Inc.
NORBERT STUIBER

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 - DPW Flowmeter, Blood, Cardiovascular

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K111730 · SONOTT FLOWLAB(R)
Download PDF FDA Summary Em-Tec GmbH