510(k) Report

FDA applicant

Mar Cor Purification, Inc.

Minneapolis, MN4 decisions2011–20201 recall

FDA records 4 decisions for Mar Cor Purification, Inc. (Minneapolis, MN) from 2011 to 2020: 4 510(k) clearances. All are in product code FIP (Subsystem, Water Purification). Its devices cite 9 predicates, 2 of them its own earlier devices. 1 recall is 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 Mar Cor Purification, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2011: 12014: 12019: 12020: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2013

2013: 1
2011high 1 (2013) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Mar Cor Purification, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Mar Cor Purification, 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?

  • FIPSubsystem, Water Purification4decisions

Whose devices does it build on?

Its devices cite 9 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 2 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.

  • K110578Millenium HX Portable Reverse Osmosis Water Purification SystemMar Cor Purification, Inc. · 20114cite it

What has FDA decided for it lately?

  • K200670EON Portable RO Water Purification SystemMar Cor Purification, Inc. · 2020
  • K192398Millenium HXMar Cor Purification, Inc. · 2019
  • K133149Biopure HX2 Reverse Osmosis Water Purification SystemMar Cor Purification, Inc. · 2014
  • K110578Millenium HX Portable Reverse Osmosis Water Purification SystemMar Cor Purification, Inc. · 20111 recall

All 4 as Mar Cor Purification, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K110578Mar Cor Purification Millenium HX Portable Reverse Osmosis System. Model 3025975.…Jun 26, 2013Class II