Xvivo Perfusion AB · Chrysalis Intelligence

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
KDN	System, Perfusion, Kidney	Class II	Gastroenterology, Urology	2	2026-07-23

Class III

PMA approvals (11)

Total PMA records

Originals + supplements

Distinct product codes

First decision

2020-04-24

Most recent

2025-11-25

Date	PMA #	Trade name	Type	Code	Device name	Specialty
2025-11-25	P180014-S013	XPS with Steen Solution Perfusate	Real-Time Process	PHO	—	—
2025-05-08	P180014-S012	XPS with Steen Solution Perfusate	Real-Time Process	PHO	—	—
2024-09-20	P180014-S011	XPS with Steen Solution Perfusate	Real-Time Process	PHO	—	—
2023-08-09	P180014-S010	XVIVO Perfusion System (XPS) with STEEN Solution	Normal 180 Day Track No User Fee	PHO	—	—
2022-07-14	P180014-S007	XVIVO Perfusion System (XPS) with STEEN Solution Perfusate	Normal 180 Day Track No User Fee	PHO	—	—
2022-05-09	P180014-S009	XVIVO Perfusion System (XPS) with STEEN Solution Perfusate	Real-Time Process	PHO	—	—
2022-05-09	P180014-S008	XVIVO Perfusion System (XPS) with STEEN Solution Perfusate	Real-Time Process	PHO	—	—
2021-11-03	P180014-S006	XVIVO Perfusion System (XPS) with STEEN Solution Perfusate	Normal 180 Day Track No User Fee	PHO	—	—
2020-10-23	P180014-S005	XVIVO Perfusion System with STEEN Solution Perfusate	Normal 180 Day Track No User Fee	PHO	—	—
2020-04-26	P180014-S004	XVIVO Perfusion System (XPS) with STEEN Solution Perfusate	Real-Time Process	PHO	—	—
2020-04-24	P180014-S003	Xvivo Perfusion System (XPS) with Steen Solution Perfusate	Real-Time Process	PHO	—	—

Safety

Recalls (1)

Class I (serious)

Risk of injury / death

Total recalls

Currently ongoing

Most recent

2022-04-08

Date	Severity	Status	Recall #	Product	Code	Reason
2022-04-08	Class II	Terminated	Z-1212-2022	XVIVO Organ Chamber REF 19020	—	The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.

Filings

All 510(k) clearances (2)

Date	K-number	Device	Code	Class	Specialty
2026-07-23	K261644	Perfadex Plus	KDN	Class II	Gastroenterology, Urology
2022-01-20	K211333	KIDNEY ASSIST-transport	KDN	Class II	Gastroenterology, Urology