Cleared Traditional

K831801 - HEMOCLAV VENOUS CATHETER

K831801 is an FDA 510(k) clearance for HEMOCLAV VENOUS CATHETER, manufactured by Exo, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIQ cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K831801 · Exo, Inc. · Gastroenterology & Urology device
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Jul 1983
Decision
34d
Days
Class 2
Risk

K831801 is an FDA 510(k) clearance for the HEMOCLAV VENOUS CATHETER. Classified as Cannula, A-v Shunt (product code FIQ), Class II - Special Controls.

Submitted by Exo, Inc. (Walker, US). The FDA issued a Cleared decision on July 7, 1983 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - 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 Exo, Inc. devices

FDA 510(k) Submission Details - K831801

510(k) Number K831801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1983
Decision Date July 07, 1983
Days to Decision 34 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
96d faster than avg
Panel avg: 130d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FIQ Device Classification - Class 2, Special Controls

Product Code FIQ Cannula, A-v Shunt
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5540
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 - FIQ Cannula, A-v Shunt

All 16
Devices cleared under the same product code (FIQ) and FDA review panel - the closest regulatory comparables to K831801.
HEMOCATH
K840415 · Quinton, Inc. · Apr 1984
HEMASITE/RENALOY -VASCULAR ACCESS SHUNT
K840436 · Renal Systems, Inc. · Feb 1984
RENALLOY HEMASITE VASCULAR ACCESS SHUNT
K833622 · Renal Systems, Inc. · Nov 1983
EXTRACORPOREAL SUBCLAVIAN CATHETER KIT
K823752 · Extracorporeal Medical Specialities, Inc. · Jan 1983
ARTERIO VENOUS SHUNT CANNULA & ADAPTORS
K822880 · Renal Systems, Inc. · Oct 1982
HEMASITE VASCULAR ACCESS SHUNT HM-1000
K813237 · Renal Systems, Inc. · Nov 1981