# Minntech Corp.

- Location (FDA's records): Minneapolis, MN
- FDA decisions: 33 (1987–2012): 33 510(k) clearances
- Product codes: KDI (11), DTZ (4), FIP (3), LIF (3), MED (2), DTN (2), LRJ (2), JOJ (1), FJF (1), FEB (1), KOC (1), DTR (1)
- Predicates its devices cite: 13 (5 its own); citations of its devices by later devices: 30 (5 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medivators, Inc.: 2 (https://510kreport.com/company/medivators)
- Ciden Technologies, LLC: 1 (https://510kreport.com/company/ciden-technologies)
- Advanced Sterilization Products: 1 (https://510kreport.com/company/advanced-sterilization-products)
- Medivators Reprocessing Systems: 1 (https://510kreport.com/company/medivators-reprocessing-systems)
- Medtronic Cardiac Surgery, Medtronic, Inc.: 1 (https://510kreport.com/company/medtronic-cardiac-surgery-medtronic)
- Sorin Biomedica, Fiat, USA, Inc.: 1 (https://510kreport.com/company/sorin-biomedica-fiat-usa)
- Scimed: 1 (https://510kreport.com/company/scimed)

## Firms that cite its devices most
- Nephros, Inc.: 4 (https://510kreport.com/company/nephros)
- Nxstage Medical, Inc.: 3 (https://510kreport.com/company/nxstage-medical)
- Maquet Cardiopulmonary, AG: 2 (https://510kreport.com/company/maquet-cardiopulmonary)
- Dynamic Technology Corp.: 2 (https://510kreport.com/company/dynamic-technology)
- Cs Medical, LLC: 1 (https://510kreport.com/company/cs-medical)
- Dideco S.P.A.: 1 (https://510kreport.com/company/dideco)
- Alcavis International, Inc.: 1 (https://510kreport.com/company/alcavis-international)
- Hdc Medical, Inc.: 1 (https://510kreport.com/company/hdc-medical)

## Its most-cited devices
- K904210: Renatron II Dialyzer Reprocessing System RS 8330 (1990), cited by 5
- K923139: Hemocor HP Hemoconcentrator Series (1994), cited by 4
- K983126: Fiberflo Hollow Fiber Capsule Water Filters (1999), cited by 3
- K923312: High Permeability Dialyer (1994), cited by 2
- K945136: Renaguard Dialysate Filter (1995), cited by 2
- K931935: Endpoint 500 Peracetic Acid Test Indicators (1994), cited by 1

## Recent decisions
- K120306: Rapicide Opa-28 (Sep 27, 2012)
- K092387: Medivators DSD Edge Endoscope Reprocessing System (Apr 5, 2010)
- K071298: HF Junior Hemofilter (Aug 8, 2007)
- K050952: HPH Junior High Performance Hemoconcentrator (Jan 31, 2006)
- K033505: Renaclean SH Dialyzer Cleaning System (Apr 27, 2004)
- K014016: Enguard CHC Dual Reservoir Cardioplegia Heater/Cooler (Feb 1, 2002)
- K991137: Enguard PHX Cardioplegia Heat Exchanger (Jun 8, 2000)
- K000028: Renaflo II HF 2000 Hemofilter (Apr 4, 2000)

Source page: https://510kreport.com/company/minntech