510(k) Report

FDA applicant

Mar Cor Services, Inc.

Harleysville, PA3 decisions1996–20010 recalls

FDA records 3 decisions for Mar Cor Services, Inc. (Harleysville, PA) from 1996 to 2001: 3 510(k) clearances. Most are in product codes FIP (Subsystem, Water Purification) and FIN (Tank, Holding, Dialysis). Its devices cite 2 predicates, 0 of them its own earlier devices. No 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 Services, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mar Cor Services, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Which product codes does it file in?

  • FIPSubsystem, Water Purification2decisions
  • FINTank, Holding, Dialysis1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 0 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.

  • K945559Mar Cor Complete Water Treatment System for Kdney DialysisMar Cor Services, Inc. · 19964cite it
  • K003560Mar Cor Services Bicarb SystemMar Cor Services, Inc. · 20012cite it
  • K003877Mar Cor Services Semper Pure RO MachineMar Cor Services, Inc. · 20011cites it

What has FDA decided for it lately?

  • K003877Mar Cor Services Semper Pure RO MachineMar Cor Services, Inc. · 2001
  • K003560Mar Cor Services Bicarb SystemMar Cor Services, Inc. · 2001
  • K945559Mar Cor Complete Water Treatment System for Kdney DialysisMar Cor Services, Inc. · 1996

All 3 as Mar Cor Services, Inc. →