Cleared Traditional

K021571 - TRANSONIC FLOW-QC SET MODEL ADT1010

K021571 is an FDA 510(k) clearance for TRANSONIC FLOW-QC SET MODEL ADT1010, manufactured by Transonic Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code MQS cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K021571 · Transonic Systems, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Aug 2002
Decision
90d
Days
Class 2
Risk

K021571 is an FDA 510(k) clearance for the TRANSONIC FLOW-QC SET MODEL ADT1010. Classified as System, Hemodialysis, Access Recirculation Monitoring (product code MQS), Class II - Special Controls.

Submitted by Transonic Systems, Inc. (Ithaca, US). The FDA issued a Cleared decision on August 12, 2002 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - the FDA gastroenterology and urology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Transonic Systems, Inc. devices

FDA 510(k) Submission Details - K021571

510(k) Number K021571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2002
Decision Date August 12, 2002
Days to Decision 90 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 131d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQS Device Classification - Class 2, Special Controls

Product Code MQS System, Hemodialysis, Access Recirculation Monitoring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - MQS System, Hemodialysis, Access Recirculation Monitoring

All 8
Devices cleared under the same product code (MQS) and FDA review panel - the closest regulatory comparables to K021571.
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K980906 · Transonic Systems, Inc. · Oct 1998