510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K000881Substantially Equivalent

Perfadex Solution for Organ Preservation

Vitrolife Sweden AB, Ringoes NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000881 is the FDA 510(k) clearance record for PERFADEX SOLUTION FOR ORGAN PRESERVATION, a class II device, cleared for Vitrolife Sweden AB on under FDA product code MSB (System And Accessories, Isolated Heart, Transport And Preservation). FDA records list 38 510(k) clearances for Vitrolife Sweden AB, from to . As of , FDA records show no recalls naming K000881.

Clearance record

Decision date
Received
(353 days to decision)
Product code
MSB System And Accessories, Isolated Heart, Transport And Preservation
Regulation
21 CFR 876.5880
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Vitrolife Sweden AB 155 Cider Mill Rd., Ringoes NJ
510(k) summary
Summary
Third party review
No

Clearances, product code MSB

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