510(k) Report

FDA applicant

Preservation Solutions, Inc.

Denver, CO6 decisions2002–20152 recalls

FDA records 6 decisions for Preservation Solutions, Inc. (Denver, CO) from 2002 to 2015: 6 510(k) clearances. Most are in product codes KDN (System, Perfusion, Kidney) and OCT (Anti Fog Solution And Accessories, Endoscopy). Its devices cite 9 predicates, 6 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 Preservation Solutions, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2008: 22009: 22015: 1
2007high 2 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2018

2010: 12018: 1
2007high 1 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Preservation Solutions, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • KDNSystem, Perfusion, Kidney5decisions
  • OCTAnti Fog Solution And Accessories, Endoscopy1decision

Whose devices does it build on?

Its devices cite 9 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 18 times; 6 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.

  • K091245CostorsolPreservation Solutions, Inc. · 20096cite it
  • K073693CostorsolPreservation Solutions, Inc. · 20085cite it
  • K083453CostorsolPreservation Solutions, Inc. · 20093cite it
  • K022826Clear-IT Anti-Fog, Model PS003Preservation Solutions, Inc. · 20023cite it
  • K080432MapersolPreservation Solutions, Inc. · 20081cites it

What has FDA decided for it lately?

  • K151728CoStorSol plus GPreservation Solutions, Inc. · 2015
  • K091245CostorsolPreservation Solutions, Inc. · 2009
  • K083453CostorsolPreservation Solutions, Inc. · 2009
  • K080432MapersolPreservation Solutions, Inc. · 2008
  • K073693CostorsolPreservation Solutions, Inc. · 20082 recalls
  • K022826Clear-IT Anti-Fog, Model PS003Preservation Solutions, Inc. · 2002

All 6 as Preservation Solutions, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K073693Cold Storage Solution, 2L, labeled as Waters IGL Cold Storage Solution, Catalog No.…Feb 26, 2018Class II
  • K073693Belzer UW Cold Storage Solution, 1000 mL. Sterile and non-pyrogenic. Formulated for…Sep 24, 2010