Cleared Traditional

K955152 - STOCKERT S3 UPS, LVL CTRL BUBB. DET., DUAL PRESS. CTRL., TEMP MONT., TIMER

K955152 is an FDA 510(k) clearance for STOCKERT S3 UPS, manufactured by Stoeckert Instrumente. The device is a Class 2 Cardiovascular device with product code DTW cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K955152 · Stoeckert Instrumente · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
101d
Days
Class 2
Risk

K955152 is an FDA 510(k) clearance for the STOCKERT S3 UPS, LVL CTRL BUBB. DET., DUAL PRESS. CTRL., TEMP MONT., TIMER. Classified as Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass (product code DTW), Class II - Special Controls.

Submitted by Stoeckert Instrumente (North Attleboro, US). The FDA issued a Cleared decision on February 22, 1996 after a review of 101 days - within the typical 510(k) review window.

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 Stoeckert Instrumente devices

FDA 510(k) Submission Details - K955152

510(k) Number K955152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1995
Decision Date February 22, 1996
Days to Decision 101 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
24d faster than avg
Panel avg: 125d · This submission: 101d
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 14
Devices cleared under the same product code (DTW) and FDA review panel - the closest regulatory comparables to K955152.
Level Sensor, Level Sensor Tape
K150530 · Medtronic, Inc. · May 2015
STOCKERTIR PURGE CONTROL (APC) SYSTEM
K041558 · Stockert Instrumente GmbH · Jul 2004
LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070
K992857 · Rocky Mountain Research, Inc. · Nov 1999
STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR
K924354 · Sorin Biomedica, Fiat, USA, Inc. · Feb 1993
CAPIOX LEVEL ALARM
K915337 · Terumo Medical Corp. · Feb 1992
COBE AIR EMBOLI PROTECTION SYSTEM (AEPS)
K900910 · Cobe Laboratories, Inc. · May 1990