510(k) Report

FDA applicant

Minntech Corp.

Minneapolis, MN33 decisions1987–20123 recalls

FDA records 33 decisions for Minntech Corp. (Minneapolis, MN) from 1987 to 2012: 33 510(k) clearances. Most are in product codes KDI (Dialyzer, High Permeability With Or Without…) and DTZ (Oxygenator, Cardiopulmonary Bypass). Its devices cite 13 predicates, 5 of them its own earlier devices. 3 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 Minntech Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2007: 12010: 12012: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2024

2015: 22024: 1
2007high 2 (2015) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Minntech Corp.’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?

  • KDIDialyzer, High Permeability With Or Without Sealed Dialysate System11decisions
  • DTZOxygenator, Cardiopulmonary Bypass4decisions
  • FIPSubsystem, Water Purification3decisions
  • LIFDialyzer Reprocessing System3decisions
  • MEDSterilant, Medical Devices2decisions
  • DTNReservoir, Blood, Cardiopulmonary Bypass2decisions

Also: LRJ (2), JOJ (1), FJF (1), FEB (1), KOC (1), DTR (1).

Whose devices does it build on?

Its devices cite 13 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 30 times; 5 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.

  • K904210Renatron II Dialyzer Reprocessing System RS 8330Minntech Corp. · 19905cite it
  • K923139Hemocor HP Hemoconcentrator SeriesMinntech Corp. · 19944cite it
  • K983126Fiberflo Hollow Fiber Capsule Water FiltersMinntech Corp. · 19993cite it
  • K923312High Permeability DialyerMinntech Corp. · 19942cite it
  • K945136Renaguard Dialysate FilterMinntech Corp. · 19952cite it
  • K931935Endpoint 500 Peracetic Acid Test IndicatorsMinntech Corp. · 19941cites it

What has FDA decided for it lately?

  • K120306Rapicide Opa-28Minntech Corp. · 2012
  • K092387Medivators DSD Edge Endoscope Reprocessing SystemMinntech Corp. · 20101 recall
  • K071298HF Junior HemofilterMinntech Corp. · 2007
  • K050952HPH Junior High Performance HemoconcentratorMinntech Corp. · 2006
  • K033505Renaclean SH Dialyzer Cleaning SystemMinntech Corp. · 2004
  • K014016Enguard CHC Dual Reservoir Cardioplegia Heater/CoolerMinntech Corp. · 2002
  • K991137Enguard PHX Cardioplegia Heat ExchangerMinntech Corp. · 2000
  • K000028Renaflo II HF 2000 HemofilterMinntech Corp. · 2000

All 33 as Minntech Corp. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K092387Hookup Model/Catalog Number: DSD-110-HU0163 Product Description: Hookups provide the…Jun 13, 2024Class II
  • K923139MEDIVATORS HEMOCOR HPH700, HPH-1400TS, HPH-1000TS. Enables the perfusionist to manage…Aug 18, 2015Class II
  • K983085Hemocor High Performance Hemoconcentrator, HPH700, sterilized with ethylene oxide The…Aug 3, 2015Class II