Cleared Traditional

K831637 - ACCU-FLUSH

K831637 is the FDA 510(k) clearance for ACCU-FLUSH by Accu-Line. It is a Class 2 Cardiovascular device (product code KRA) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K831637 · Accu-Line · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1983
Decision
38d
Days
Class 2
Risk

K831637 is an FDA 510(k) clearance for the ACCU-FLUSH. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Accu-Line (Mchenry, US). The FDA issued a Cleared decision on June 30, 1983 after a review of 38 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 Accu-Line devices

Submission Details

510(k) Number K831637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1983
Decision Date June 30, 1983
Days to Decision 38 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 125d · This submission: 38d
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 129
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K831637.
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
FLUSHFLO II
K812173 · Bentley Laboratories, Inc. · Aug 1981
MEDI-TRACE
K811410 · Graphic Controls Corp. · Jun 1981
MEDI-TRACE DISP. FLUSHING DEV./MONITOR
K801829 · Graphic Controls Corp. · Aug 1980