Cleared Traditional

K812890 - HEMASITE GRAFTLESS VASCULAR ACESS

K812890 is the FDA 510(k) clearance for HEMASITE GRAFTLESS VASCULAR ACESS by Renal Systems, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FIQ) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K812890 · Renal Systems, Inc. · Gastroenterology & Urology device
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Nov 1981
Decision
32d
Days
Class 2
Risk

K812890 is an FDA 510(k) clearance for the HEMASITE GRAFTLESS VASCULAR ACESS. Classified as Cannula, A-v Shunt (product code FIQ), Class II - Special Controls.

Submitted by Renal Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 16, 1981 after a review of 32 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 Renal Systems, Inc. devices

Submission Details

510(k) Number K812890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1981
Decision Date November 16, 1981
Days to Decision 32 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
98d faster than avg
Panel avg: 130d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 15
Devices cleared under the same product code (FIQ) and FDA review panel - the closest regulatory comparables to K812890.
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
HEMASITE VASCULAR ACCESS SHUNT
K811384 · Renal Systems, Inc. · Jul 1981
VASCULAR ACCESS SYSTEM
K810114 · Bentley Laboratories, Inc. · Mar 1981
SSC8 SORENSON SUBCLAVIAN CATHETER
K801478 · Sorensen Research · Aug 1980