Cleared Traditional

K925615 - SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE

K925615 is an FDA 510(k) clearance for SHILEY SPECIALIZED, manufactured by Sorin Biomedica, Fiat, USA, Inc.. The device is a Class 2 Anesthesiology device with product code CBI cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K925615 · Sorin Biomedica, Fiat, USA, Inc. · Anesthesiology device
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Mar 1993
Decision
140d
Days
Class 2
Risk

K925615 is an FDA 510(k) clearance for the SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE. Classified as Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) (product code CBI), Class II - Special Controls.

Submitted by Sorin Biomedica, Fiat, USA, Inc. (Irvine, US). The FDA issued a Cleared decision on March 26, 1993 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5740 - the FDA anesthesiology and respiratory device 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 Anesthesiology 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 - K925615

510(k) Number K925615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1992
Decision Date March 26, 1993
Days to Decision 140 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 140d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBI Device Classification - Class 2, Special Controls

Product Code CBI Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5740
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - CBI Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector)

All 21
Devices cleared under the same product code (CBI) and FDA review panel - the closest regulatory comparables to K925615.
BRONCHIAL BLOCKER
K962167 · Cook, Inc. · Aug 1997
KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBE
K961977 · Kendall Healthcare Products Co. Div.Of Tyco Health · Jul 1996
SIMS BLUE LINE ENDOBRONCHIAL TUBE
K953483 · Smiths Industries Medical Systems, Inc. · Oct 1995
LASER RESISTANT TRACHEAL TUBE
K897046 · Sheridan Catheter Corp. · Mar 1990
TRACHEAL/BRONCHIAL DIFFERENTIAL VENTILATION TUBE
K851856 · Sheridan Catheter Corp. · May 1985