Cleared Traditional

K925541 - STOCKERT 1/4 BUBBLE SENSOR

K925541 is the FDA 510(k) clearance for STOCKERT 1/4 BUBBLE SENSOR by Sorin Biomedica, Fiat, USA, Inc.. It is a Class 2 Cardiovascular device (product code KRL) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K925541 · Sorin Biomedica, Fiat, USA, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1993
Decision
91d
Days
Class 2
Risk

K925541 is an FDA 510(k) clearance for the STOCKERT 1/4 BUBBLE SENSOR. 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 February 2, 1993 after a review of 91 days - within the typical 510(k) review window.

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

Submission Details

510(k) Number K925541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1992
Decision Date February 02, 1993
Days to Decision 91 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 125d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Devices cleared under the same product code (KRL) and FDA review panel - the closest regulatory comparables to K925541.
SARNS ULTRASONIC AIR SENSOR
K940651 · 3M Health Care, Sarns · May 1994
SARNS AIR DETECTION SYSTEM
K935977 · 3M Health Care, Sarns · Feb 1994
CAPIOX(R) BUBBLE TRAP
K911632 · Terumo Medical Corp. · Jul 1991
CAPS LOW LEVEL DETECTOR & DETECTOR/BUBBLE MONITOR
K864619 · Shiley, Inc. · Feb 1987
COBE ACCESSORY INTERFACE MODULE (AIM)
K861860 · Cobe Laboratories, Inc. · Jul 1986
COBE AEPS
K842054 · Cobe Laboratories, Inc. · Aug 1984