Cleared Traditional

K810114 - VASCULAR ACCESS SYSTEM

K810114 is an FDA 510(k) clearance for VASCULAR ACCESS SYSTEM, manufactured by Bentley Laboratories, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIQ cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K810114 · Bentley Laboratories, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1981
Decision
101d
Days
Class 2
Risk

K810114 is an FDA 510(k) clearance for the VASCULAR ACCESS SYSTEM. Classified as Cannula, A-v Shunt (product code FIQ), Class II - Special Controls.

Submitted by Bentley Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 26, 1981 after a review of 101 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bentley Laboratories, Inc. devices

FDA 510(k) Submission Details - K810114

510(k) Number K810114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1980
Decision Date March 26, 1981
Days to Decision 101 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
30d faster than avg
Panel avg: 131d · This submission: 101d
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 K810114.
HEMASITE VASCULAR ACCESS SHUNT HM-1000
K813237 · Renal Systems, Inc. · Nov 1981
HEMASITE GRAFTLESS VASCULAR ACESS
K812890 · Renal Systems, Inc. · Nov 1981
HEMASITE VASCULAR ACCESS SHUNT
K811384 · Renal Systems, Inc. · Jul 1981
SSC8 SORENSON SUBCLAVIAN CATHETER
K801478 · Sorensen Research · Aug 1980
ULDALL SUBCLAVIAN CANNULA SC-100
K791308 · Vas-Cath of Canada , Ltd. · Aug 1979
SILASTIC BRAND PENILE IMPLANT
K780484 · Dow Corning Corp. Healthcare Industries Materials · Jul 1978