510(k) Report

FDA applicant

Organ Recovery Systems, Inc.

Charleston, SC4 decisions2002–20102 recalls

FDA records 4 decisions for Organ Recovery Systems, Inc. (Charleston, SC) from 2002 to 2010: 4 510(k) clearances. Most are in product codes KDN (System, Perfusion, Kidney) and KDL (Set, Perfusion, Kidney, Disposable). Its devices cite 4 predicates, 1 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Organ Recovery Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2020

2016: 12020: 1
2007high 1 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Organ Recovery Systems, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KDNSystem, Perfusion, Kidney3decisions
  • KDLSet, Perfusion, Kidney, Disposable1decision

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K021362Lifeport, Kidney Perfusion Transporter (KTR)Organ Recovery Systems, Inc. · 20033cite it
  • K091656SPS-1TM Static Preservation Solution, Models SPS-1-500 ML, SPS 1-1L, SPS-1-2LOrgan Recovery Systems, Inc. · 20101cites it
  • K022391Modification to KPS-1, Kidney Perfusion SolutiionOrgan Recovery Systems, Inc. · 20021cites it
  • K013575KPS-I, the Kidney Perfusion SolutionOrgan Recovery Systems, Inc. · 20021cites it

What has FDA decided for it lately?

  • K091656SPS-1TM Static Preservation Solution, Models SPS-1-500 ML, SPS 1-1L, SPS-1-2LOrgan Recovery Systems, Inc. · 20101 recall
  • K021362Lifeport, Kidney Perfusion Transporter (KTR)Organ Recovery Systems, Inc. · 20031 recall
  • K022391Modification to KPS-1, Kidney Perfusion SolutiionOrgan Recovery Systems, Inc. · 2002
  • K013575KPS-I, the Kidney Perfusion SolutionOrgan Recovery Systems, Inc. · 2002

All 4 as Organ Recovery Systems, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K021362LKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR - Product…Jan 30, 2020Class II
  • K091656SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery…Dec 14, 2016Class II