Cleared Traditional

K103469 - STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05

K103469 is an FDA 510(k) clearance for STOCKERT AIR PURGE CONTROL SYSTEM MODEL..., manufactured by Sorin Group Deutschland GmbH. The device is a Class 2 Cardiovascular device with product code KRL cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K103469 · Sorin Group Deutschland GmbH · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
55d
Days
Class 2
Risk

K103469 is an FDA 510(k) clearance for the STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05. Classified as Detector, Bubble, Cardiopulmonary Bypass (product code KRL), Class II - Special Controls.

Submitted by Sorin Group Deutschland GmbH (North Attleboro, US). The FDA issued a Cleared decision on January 18, 2011 after a review of 55 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K103469

510(k) Number K103469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2010
Decision Date January 18, 2011
Days to Decision 55 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
70d faster than avg
Panel avg: 125d · This submission: 55d
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 13
Devices cleared under the same product code (KRL) and FDA review panel - the closest regulatory comparables to K103469.
CAPIOX BUBBLE TRAP WITH X-COATING
K090698 · Terumo Cardiovascular Systems · Jun 2009
EDAC QUANTIFIER
K071231 · Luna Innovations, Inc. · May 2007
AUTOMATIC TUBING CLAMP SYSTEM (ATC)
K961364 · Rocky Mountain Research, Inc. · Oct 1996
ELS AUTOMATIC TUBING CLAMP SYSTEM
K961598 · Rocky Mountain Research, Inc. · Oct 1996
SARNS ULTRASONIC AIR SENSOR
K940651 · 3M Health Care, Sarns · May 1994
SARNS AIR DETECTION SYSTEM
K935977 · 3M Health Care, Sarns · Feb 1994