Cleared Traditional

K892887 - ST SERIES SAF-T-SHUNTS ARTERIOVENOUS CANNULA

K892887 is an FDA 510(k) clearance for ST SERIES SAF-T-SHUNTS ARTERIOVENOUS CA..., manufactured by Akcess Medical Products, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIQ cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K892887 · Akcess Medical Products, Inc. · Gastroenterology & Urology device
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May 1989
Decision
25d
Days
Class 2
Risk

K892887 is an FDA 510(k) clearance for the ST SERIES SAF-T-SHUNTS ARTERIOVENOUS CANNULA. Classified as Cannula, A-v Shunt (product code FIQ), Class II - Special Controls.

Submitted by Akcess Medical Products, Inc. (New Brunswick, US). The FDA issued a Cleared decision on May 15, 1989 after a review of 25 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 Akcess Medical Products, Inc. devices

FDA 510(k) Submission Details - K892887

510(k) Number K892887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1989
Decision Date May 15, 1989
Days to Decision 25 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
106d faster than avg
Panel avg: 131d · This submission: 25d
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 18
Devices cleared under the same product code (FIQ) and FDA review panel - the closest regulatory comparables to K892887.
S-100 ALLEN-BROWN SHUNT
K892663 · Akcess Medical Products, Inc. · May 1989
SAF-T-SHUNT, S-300 SERIES
K892666 · Akcess Medical Products, Inc. · May 1989
PEDIATRIC SIZED HEMOCATH CATHETER
K844692 · Quinton, Inc. · Jan 1985
PLUME FISTULA NEEDLE
K841791 · Hospal Medical Corp. · Jul 1984
HEMOFILTRATION CATHETER HF-100
K840322 · Vas-Cath of Canada , Ltd. · Apr 1984
HEMOCATH
K840415 · Quinton, Inc. · Apr 1984