Cleared Traditional

SONTEK INFUSION CATHETER (K831562) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K831562 · Sontek Corp. · Cardiovascular device
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Jun 1983
Decision
45d
Days
Class 2
Risk

K831562 is an FDA 510(k) clearance for the SONTEK INFUSION CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Sontek Corp. (Mchenry, US). The FDA issued a Cleared decision on June 30, 1983 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 Sontek Corp. devices

Submission Details

510(k) Number K831562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1983
Decision Date June 30, 1983
Days to Decision 45 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 125d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 156
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K831562.
MODIFIED CORDIS PTCA GUIDING CATHETERS
K854576 · Cordis Corp. · Feb 1986
PTCA GUIDING CATHER
K844161 · Cordis Corp. · Jan 1985
PERCLUDER DL OCCLUDING BALLOON
K832386 · Datascope Corp. · Oct 1983
VARIOUS CARDIOVASCULAR PRODUCTS
K823357 · C.R. Bard, Inc. · Mar 1983
USCI CARDIOVASCULAR CATHETER
K810412 · C.R. Bard, Inc. · Mar 1981
STERI-SLEEVE
K802629 · Cordis Corp. · Oct 1980