510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K925615Substantially Equivalent

Shiley Specialized,pediatric & Neonatal Trach.tube

Sorin Biomedica, Fiat, USA, Inc., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K925615 is the FDA 510(k) clearance record for SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE, a class II device, cleared for Sorin Biomedica, Fiat, USA, Inc. on under FDA product code CBI (Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)). FDA records list 20 510(k) clearances for Sorin Biomedica, Fiat, USA, Inc., from to . As of , FDA records show 5 recalls naming K925615.

Clearance record

Decision date
Received
(140 days to decision)
Product code
CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Regulation
21 CFR 868.5740
Device class
Class II
Review panel
Anesthesiology
Applicant
Sorin Biomedica, Fiat, USA, Inc. 17600 Gilette Ave., Irvine CA
510(k) summary
Statement
Third party review
No

Clearances, product code CBI

Trailing 12 months
2 clearances under product code CBI in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CBI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260