Cleared Traditional

K821316 - KONTRON LITWAK-KOFFSKY OBTURATED CANNU

K821316 is an FDA 510(k) clearance for KONTRON LITWAK-KOFFSKY OBTURATED CANNU, manufactured by Kontron Instruments, Inc.. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K821316 · Kontron Instruments, Inc. · Cardiovascular device
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Aug 1982
Decision
94d
Days
Class 2
Risk

K821316 is an FDA 510(k) clearance for the KONTRON LITWAK-KOFFSKY OBTURATED CANNU. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Kontron Instruments, Inc. (Walker, US). The FDA issued a Cleared decision on August 6, 1982 after a review of 94 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Kontron Instruments, Inc. devices

FDA 510(k) Submission Details - K821316

510(k) Number K821316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1982
Decision Date August 06, 1982
Days to Decision 94 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
31d faster than avg
Panel avg: 125d · This submission: 94d
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 269
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K821316.
AORTIC ROOT CANNULA W/INTEGRAL PRESS
K831591 · Dlp, Inc. · Jun 1983
ARGYLE CAROTID ARTERY LOOP SHUNT
K822317 · Sherwood Medical Co. · Aug 1982
SARNS CARDIOPLEGIA CANNULAE (VAR. TYPES
K822210 · 3M Health Care, Sarns · Aug 1982
ARGYLE FERGUSON LEFT ATRIAL VENT CATH
K821445 · Sherwood Medical Co. · Jul 1982
SUBMISSION CORONARY CANNULA
K821149 · Dlp, Inc. · May 1982
DISPOSABLE 2-STAGE CANNULA
K810515 · Texas Medical Products, Inc. · Apr 1981