Cleared Traditional

K920671 - DIGI -FLOW

K920671 is an FDA 510(k) clearance for DIGI -FLOW, manufactured by D and D Technology, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KOC cleared through the Traditional 510(k) pathway after a 350-day FDA review.

K920671 · D and D Technology, Inc. · Gastroenterology & Urology device
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Jan 1993
Decision
350d
Days
Class 2
Risk

K920671 is an FDA 510(k) clearance for the DIGI -FLOW. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by D and D Technology, Inc. (Buffalo, US). The FDA issued a Cleared decision on January 28, 1993 after a review of 350 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 D and D Technology, Inc. devices

FDA 510(k) Submission Details - K920671

510(k) Number K920671 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1992
Decision Date January 28, 1993
Days to Decision 350 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
220d slower than avg
Panel avg: 130d · This submission: 350d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOC Device Classification - Class 2, Special Controls

Product Code KOC Accessories, Blood Circuit, Hemodialysis
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 - KOC Accessories, Blood Circuit, Hemodialysis

All 123
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K920671.
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