Cleared Traditional

K850925 - BLOOD TUBING(PVC) 201458 W/(TOTM) PLASTICIZER

K850925 is an FDA 510(k) clearance for BLOOD TUBING(PVC) 201458 W/(TOTM) PLAST..., manufactured by American Bentley. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K850925 · American Bentley · Cardiovascular device
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May 1985
Decision
77d
Days
Class 2
Risk

K850925 is an FDA 510(k) clearance for the BLOOD TUBING(PVC) 201458 W/(TOTM) PLASTICIZER. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by American Bentley (Irvine, US). The FDA issued a Cleared decision on May 21, 1985 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4210 - the FDA cardiovascular device oversight 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 American Bentley devices

FDA 510(k) Submission Details - K850925

510(k) Number K850925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1985
Decision Date May 21, 1985
Days to Decision 77 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 125d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWF Device Classification - Class 2, Special Controls

Product Code DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4210
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

All 303
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K850925.
AMENDMENT WILLIAM HARVEY H-4300 CARDIOPULMONARY SU
K851323 · C.R. Bard, Inc. · Aug 1985
DOSIMETRIC RELEASE OF RAD. TUBING PAC
K833047 · American Bentley · Jun 1985
ARGYLE GRIFFITH TDMAC HEPARINIZED VENO-VENOUS SHUN
K850917 · Sherwood Medical Co. · May 1985
INTRACARDIAC SUMP 12010
K850385 · Dlp, Inc. · Apr 1985
VENOUS RETURN CATHETER SS-1
K845045 · Dlp, Inc. · Apr 1985
PUL,MONARY ARTERY VENT CATHETER
K845046 · Dlp, Inc. · Apr 1985