Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

MSB — Predicate Candidate Screening

13 FDA 510(k) clearances under this product code; the 50 most recent screened below.

90 daysmedian FDA review time

353 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K222535	OCS Lung Donor Flush Set	TransMedics, Inc.	2022-11-18	88	0
K211314	OCS Lung Solution	TransMedics, Inc.	2021-07-29	90	0
K190063	Servator C SALF Solution	S.A.L.F. Spa	2019-08-14	211	0
K182735	Paragonix SherpaPak Cardiac Transport System	Paragonix Technologies	2018-10-19	21	0
K180194	SherpaPak Cardiac Transport System and SherpaPak Kidney Tran	Paragonix Technologies, Inc.	2018-03-30	65	0
K143074	Sherpa Pak Cardiac Transport System	Paragonix Technologies, Inc.	2014-11-25	29	0
K133432	SHERPA PAK CARDIAC TRANSPORT SYSTEM	Paragonix Technologies, Inc.	2014-02-21	108	0
K123326	SHERPA PAK CARDIAC TRANSPORT SYSTEM	Paragonix Technologies, Inc.	2013-02-06	103	0
K081997	PERFADEX WITH THAM	Vitrolife Sweden AB	2008-10-09	87	1
K032794	CUSTODIOL	Dr. Franz Kohler Chemie GmbH	2004-04-05	210	0
K022730	PERFADEX SOLUTION FOR LUNG PRESERVATION	Vitrolife AB	2003-10-27	437	0
K000881	PERFADEX SOLUTION FOR ORGAN PRESERVATION	Vitrolife Sweden AB	2001-03-08	353	0
K991594	CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEART	Sangstat Medical Corp.	1999-08-05	90	1

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda