Cleared Traditional

K770047 - DNC 151 VINCA-FLO

K770047 is an FDA 510(k) clearance for DNC 151 VINCA-FLO, manufactured by Sorensen Research. The device is a Class 2 Gastroenterology & Urology device with product code FJT cleared through the Traditional 510(k) pathway after a 4-day FDA review.

K770047 · Sorensen Research · Gastroenterology & Urology device
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Jan 1977
Decision
4d
Days
Class 2
Risk

K770047 is an FDA 510(k) clearance for the DNC 151 VINCA-FLO. Classified as Intracatheter, Dialysis (product code FJT), 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 - K770047

510(k) Number K770047 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.

FJT Device Classification - Class 2, Special Controls

Product Code FJT Intracatheter, Dialysis
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 - FJT Intracatheter, Dialysis

Devices cleared under the same product code (FJT) and FDA review panel - the closest regulatory comparables to K770047.
MODIFICATION'S TO TORAY'S B-2 SERIES
K863297 · National Medical Care, Medical Products Div., Inc. · Sep 1986
CATHETER, VEIN, FEMORAL, SF 10
K772146 · Sorensen Research · Nov 1977
CATHETER, FEMORAL VEIN, SF 6
K772148 · Sorensen Research · Nov 1977
TRIEX-1 HOLLOW FIBER DIALYZER
K760781 · Extracorporeal Medical Specialities, Inc. · Dec 1976