Cleared Traditional

K770044 - DNC 141 VINCA-FLO

K770044 is an FDA 510(k) clearance for DNC 141 VINCA-FLO, manufactured by Sorensen Research. The device is a Class 2 Gastroenterology & Urology device with product code KOC cleared through the Traditional 510(k) pathway after a 4-day FDA review.

K770044 · Sorensen Research · Gastroenterology & Urology device
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Jan 1977
Decision
4d
Days
Class 2
Risk

K770044 is an FDA 510(k) clearance for the DNC 141 VINCA-FLO. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Sorensen Research (Mchenry, US). The FDA issued a Cleared decision on January 14, 1977 after a review of 4 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sorensen Research devices

FDA 510(k) Submission Details - K770044

510(k) Number K770044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1977
Decision Date January 14, 1977
Days to Decision 4 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
127d faster than avg
Panel avg: 131d · This submission: 4d
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 134
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K770044.
STOPCOCK, ONE WAY
K770383 · Cobe Laboratories, Inc. · Mar 1977
BARIOR
K770213 · Tri-Med, Inc. · Feb 1977
DNC 161 VINCA-FLO
K770043 · Sorensen Research · Jan 1977
DNC 152 VINCA-FLO
K770045 · Sorensen Research · Jan 1977
DNC 142 VINCA-FLO
K770046 · Sorensen Research · Jan 1977
DNC 162 VINCA-FLO
K770048 · Sorensen Research · Jan 1977