Cleared Traditional

K831730 - CONTINUOUS FLUSH DEVICE

K831730 is an FDA 510(k) clearance for CONTINUOUS FLUSH DEVICE, manufactured by American Pharmaseal Div. Ahsc. The device is a Class 2 Cardiovascular device with product code KRA cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K831730 · American Pharmaseal Div. Ahsc · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1983
Decision
48d
Days
Class 2
Risk

K831730 is an FDA 510(k) clearance for the CONTINUOUS FLUSH DEVICE. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by American Pharmaseal Div. Ahsc (Mchenry, US). The FDA issued a Cleared decision on July 18, 1983 after a review of 48 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 American Pharmaseal Div. Ahsc devices

FDA 510(k) Submission Details - K831730

510(k) Number K831730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1983
Decision Date July 18, 1983
Days to Decision 48 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
77d faster than avg
Panel avg: 125d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRA Device Classification - Class 2, Special Controls

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 130
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K831730.
JEHLE CORONARY PERFUSION CATHETERS
K874242 · Pilling Co. · Dec 1987
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
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