Cleared Abbreviated

SONOTT FLOWLAB(R) (K111730) - FDA 510(k) Clearance

Class II Radiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K111730 · Em-Tec GmbH · Radiology device
Download Printable Device Report (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.

View all Em-Tec GmbH devices

Submission Details

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
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.

Device Classification

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 Peers - DPW Flowmeter, Blood, Cardiovascular

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