MSB · Class II · 21 CFR 876.5880

FDA Product Code MSB: System And Accessories, Isolated Heart, Transport And Preservation

Leading manufacturers include Paragonix Technologies, Inc., Vitrolife Sweden AB and TransMedics, Inc..

14
Total
14
Cleared
142d
Avg days
1999
Since
Stable submission activity - 1 submissions in the last 2 years
Review times improving: avg 100d recently vs 146d historically

FDA 510(k) Cleared System And Accessories, Isolated Heart, Transport And Preservation Devices (Product Code MSB)

14 devices
1–14 of 14
Cleared Sep 16, 2026
X°Port Heart Preservation System
K261913
Traferox Technologies, Inc.
Cardiovascular · 100d
Cleared Nov 18, 2022
OCS Lung Donor Flush Set
K222535
TransMedics, Inc.
Gastroenterology & Urology · 88d
Cleared Jul 29, 2021
OCS Lung Solution
K211314
TransMedics, Inc.
Gastroenterology & Urology · 90d
Cleared Aug 14, 2019
Servator C SALF Solution
K190063
S.A.L.F. Spa
Gastroenterology & Urology · 211d
Cleared Oct 19, 2018
Paragonix SherpaPak Cardiac Transport System
K182735
Paragonix Technologies
Gastroenterology & Urology · 21d
Cleared Mar 30, 2018
SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System
K180194
Paragonix Technologies, Inc.
Gastroenterology & Urology · 65d
Cleared Nov 25, 2014
Sherpa Pak Cardiac Transport System
K143074
Paragonix Technologies, Inc.
Gastroenterology & Urology · 29d
Cleared Feb 21, 2014
SHERPA PAK CARDIAC TRANSPORT SYSTEM
K133432
Paragonix Technologies, Inc.
Gastroenterology & Urology · 108d
Cleared Feb 06, 2013
SHERPA PAK CARDIAC TRANSPORT SYSTEM
K123326
Paragonix Technologies, Inc.
Gastroenterology & Urology · 103d
Cleared Oct 09, 2008
PERFADEX WITH THAM
K081997
Vitrolife Sweden AB
Gastroenterology & Urology · 87d
Cleared Mar 08, 2001
PERFADEX SOLUTION FOR ORGAN PRESERVATION
K000881
Vitrolife Sweden AB
Gastroenterology & Urology · 353d
Cleared Aug 05, 1999
CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS
K991594
Sangstat Medical Corp.
Gastroenterology & Urology · 90d

About Product Code MSB - Regulatory Context

510(k) Submission Activity

14 total 510(k) submissions under product code MSB since 1999, with 14 receiving FDA clearance (average review time: 142 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA 510(k) Review Time - MSB Product Code

Recent submissions under MSB have taken an average of 100 days to reach a decision - down from 146 days historically, suggesting improved FDA processing for this classification.

MSB devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →