Cleared Traditional

K812173 - FLUSHFLO II

K812173 is the FDA 510(k) clearance for FLUSHFLO II by Bentley Laboratories, Inc.. It is a Class 2 Cardiovascular device (product code KRA) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K812173 · Bentley Laboratories, Inc. · Cardiovascular device
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Aug 1981
Decision
15d
Days
Class 2
Risk

K812173 is an FDA 510(k) clearance for the FLUSHFLO II. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Bentley Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on August 18, 1981 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1210 - 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 Bentley Laboratories, Inc. devices

Submission Details

510(k) Number K812173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1981
Decision Date August 18, 1981
Days to Decision 15 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
110d faster than avg
Panel avg: 125d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRA Catheter, Continuous Flush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1210
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 - KRA Catheter, Continuous Flush

All 127
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K812173.
ANGIO-FLO CONTINUOUS ARTERIAL CATH FLUSH DEVICE
K860570 · Parke-Davis Co. · Mar 1986
ANGIO-FLO CONTIN-ARTERIAL FLUSH DEV.
K832058 · Parke-Davis Co. · Sep 1983
CONTINUOUS FLUSH DEVICE
K831730 · American Pharmaseal Div. Ahsc · Jul 1983
MEDI-TRACE
K811410 · Graphic Controls Corp. · Jun 1981
MEDI-TRACE DISP. FLUSHING DEV./MONITOR
K801829 · Graphic Controls Corp. · Aug 1980
CONTINUOUS FLUSH DEVICE, CAT. #14-370
K791890 · Norton Performance Plastics Corp. · Dec 1979