Cleared Traditional

K801355 - BIONICS BI-FLO STRETCH(DOUBLE LUMEN FOR

K801355 is an FDA 510(k) clearance for BIONICS BI-FLO STRETCH(DOUBLE LUMEN FOR, manufactured by Cordis Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KOC cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K801355 · Cordis Corp. · Gastroenterology & Urology device
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Jul 1980
Decision
29d
Days
Class 2
Risk

K801355 is an FDA 510(k) clearance for the BIONICS BI-FLO STRETCH(DOUBLE LUMEN FOR. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Cordis Corp. (Walker, US). The FDA issued a Cleared decision on July 8, 1980 after a review of 29 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 Cordis Corp. devices

FDA 510(k) Submission Details - K801355

510(k) Number K801355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1980
Decision Date July 08, 1980
Days to Decision 29 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
101d faster than avg
Panel avg: 130d · This submission: 29d
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 124
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K801355.
ISOLATER THP
K811981 · Tri-Med, Inc. · Aug 1981
HEMASITE ACCESS MONITOR (TENT.) #RS-8200
K811977 · Renal Systems, Inc. · Jul 1981
BIONICS ARTERIAL/VENOUS FISTULA NEEDLE
K801354 · Cordis Corp. · Jul 1980
BIONICS BI-FLO SAFE(DOUBLE LUMEN CATHET
K801356 · Cordis Corp. · Jul 1980
COAXIAL DUAL FLOW CATHETER
K791411 · Terumo America, Inc. · Nov 1979
TG 2, TRI-GARD PRESSURE MONITOR
K790841 · Sorensen Research · Jun 1979