Cleared Traditional

K924354 - STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR

K924354 is an FDA 510(k) clearance for STOCKERT CAPS LOW LEVEL DETECT II/BUBBL..., manufactured by Sorin Biomedica, Fiat, USA, Inc.. The device is a Class 2 Cardiovascular device with product code DTW cleared through the Traditional 510(k) pathway after a 190-day FDA review.

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

FDA 510(k) Submission Details - K924354

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
Combination Product No
PCCP Authorized No
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.

DTW Device Classification - Class 2, Special Controls

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.

Regulatory Peers - DTW Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass

All 11
Devices cleared under the same product code (DTW) and FDA review panel - the closest regulatory comparables to K924354.
Level Sensor, Level Sensor Tape
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K873206 · Respiratory Support Products, Inc. · Sep 1987
GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200
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