Cleared Traditional

K925661 - STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE

K925661 is an FDA 510(k) clearance for STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE, manufactured by Sorin Biomedica, Fiat, USA, Inc.. The device is a Class 2 Cardiovascular device with product code KRL cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K925661 · Sorin Biomedica, Fiat, USA, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1993
Decision
189d
Days
Class 2
Risk

K925661 is an FDA 510(k) clearance for the STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE. Classified as Detector, Bubble, Cardiopulmonary Bypass (product code KRL), Class II - Special Controls.

Submitted by Sorin Biomedica, Fiat, USA, Inc. (Irvine, US). The FDA issued a Cleared decision on May 18, 1993 after a review of 189 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4205 - 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 Sorin Biomedica, Fiat, USA, Inc. devices

FDA 510(k) Submission Details - K925661

510(k) Number K925661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 1992
Decision Date May 18, 1993
Days to Decision 189 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 125d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRL Device Classification - Class 2, Special Controls

Product Code KRL Detector, Bubble, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4205
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 - KRL Detector, Bubble, Cardiopulmonary Bypass

All 9
Devices cleared under the same product code (KRL) and FDA review panel - the closest regulatory comparables to K925661.
STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05
K103469 · Sorin Group Deutschland GmbH · Jan 2011
SARNS ULTRASONIC AIR SENSOR
K940651 · 3M Health Care, Sarns · May 1994
SARNS AIR DETECTION SYSTEM
K935977 · 3M Health Care, Sarns · Feb 1994
STOCKERT 1/4 BUBBLE SENSOR
K925541 · Sorin Biomedica, Fiat, USA, Inc. · Feb 1993
CAPIOX(R) BUBBLE TRAP
K911632 · Terumo Medical Corp. · Jul 1991
CAPS LOW LEVEL DETECTOR & DETECTOR/BUBBLE MONITOR
K864619 · Shiley, Inc. · Feb 1987