Cleared Traditional

K761051 - BI-FLOW NEEDLE

K761051 is an FDA 510(k) clearance for BI-FLOW NEEDLE, manufactured by Dws, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KOC cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K761051 · Dws, Inc. · Gastroenterology & Urology device
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Dec 1976
Decision
45d
Days
Class 2
Risk

K761051 is an FDA 510(k) clearance for the BI-FLOW NEEDLE. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Dws, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 30, 1976 after a review of 45 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 Dws, Inc. devices

FDA 510(k) Submission Details - K761051

510(k) Number K761051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1976
Decision Date December 30, 1976
Days to Decision 45 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 130d · This submission: 45d
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 K761051.
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
SINGLE NEEDLE HEMODIALYSIS
K761038 · Sorensen Research · Dec 1976
SINGLE NEEDLE HEMODIALYSIS (BFC-161)
K761081 · Sorensen Research · Dec 1976
SINGLE NEEDLE HEMODIALYSIS (BFC-142)
K761082 · Sorensen Research · Dec 1976