Cleared Traditional

K924354 - STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR (FDA 510(k) Clearance)

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

K924354 · Sorin Biomedica, Fiat, USA, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1993
Decision
190d
Days
Class 2
Risk

K924354 is an FDA 510(k) clearance for the STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR. Classified as Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass (product code DTW), Class II - Special Controls.

Submitted by Sorin Biomedica, Fiat, USA, Inc. (Irvine, US). The FDA issued a Cleared decision on February 18, 1993 after a review of 190 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4340 - 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 K924354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1992
Decision Date February 18, 1993
Days to Decision 190 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
65d slower than avg
Panel avg: 125d · This submission: 190d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTW Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4340
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.