Cleared Traditional

K040909 - SONO TT ULTRASONIC FLOWCOMPUTER

K040909 is an FDA 510(k) clearance for SONO TT ULTRASONIC FLOWCOMPUTER, manufactured by Em-Tec GmbH. The device is a Class 2 Cardiovascular device with product code DPW cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K040909 · Em-Tec GmbH · Cardiovascular device
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Apr 2004
Decision
12d
Days
Class 2
Risk

K040909 is an FDA 510(k) clearance for the SONO TT ULTRASONIC FLOWCOMPUTER. 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 April 20, 2004 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2100 - the FDA cardiovascular device oversight 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.

FDA 510(k) Submission Details - K040909

510(k) Number K040909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2004
Decision Date April 20, 2004
Days to Decision 12 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 125d · This submission: 12d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. 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 Cardiovascular devices follow this clearance model.

Regulatory Consultant

Tuv America, Inc.
STEFAN PREISS

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

All 100
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K040909 · SONO TT ULTRASONIC FLOWCOMPUTER
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