Cleared Traditional

K761082 - SINGLE NEEDLE HEMODIALYSIS (BFC-142)

K761082 is the FDA 510(k) clearance for SINGLE NEEDLE HEMODIALYSIS (BFC-142) by Sorensen Research. It is a Class 2 Gastroenterology & Urology device (product code KOC) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K761082 · Sorensen Research · Gastroenterology & Urology device
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Dec 1976
Decision
17d
Days
Class 2
Risk

K761082 is an FDA 510(k) clearance for the SINGLE NEEDLE HEMODIALYSIS (BFC-142). 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 December 6, 1976 after a review of 17 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

Submission Details

510(k) Number K761082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1976
Decision Date December 06, 1976
Days to Decision 17 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
113d faster than avg
Panel avg: 130d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 80
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K761082.
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
WINGED FISTULA NEEDLE
K760935 · Gambro, Inc. · Nov 1976
FISTULA NEEDLE (#11-265)
K760665 · Cobe Laboratories, Inc. · Oct 1976
FILTER SET PMF 1168
K760625 · Sorensen Research · Oct 1976