Minntech Corp.: FDA filings under this applicant name
FDA lists 33 510(k) clearances under the applicant name “Minntech Corp.” (first 1987, latest 2012), across 13 product codes in 3 review panels. Median 510(k) review time under this name: 103 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under STERIS, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 239 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 11 | 11 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 4 | 4 |
| FIP | Subsystem, Water Purification | 3 | 3 |
| LIF | Dialyzer Reprocessing System | 3 | 3 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 2 | 2 |
| LRJ | Disinfectant, Medical Devices | 2 | 2 |
| MED | Sterilant, Medical Devices | 2 | 2 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 1 | 1 |
| DWC | Controller, Temperature, Cardiopulmonary Bypass | 1 | 1 |
| FEB | Accessories, Cleaning, For Endoscope | 1 | 1 |
Plus 3 more product codes.
Review panels
Most recent Minntech Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K120306 | RAPICIDE OPA-28 | MED | 2012-09-27 | 239 |
| K092387 | MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEM | FEB | 2010-04-05 | 243 |
| K071298 | HF JUNIOR HEMOFILTER | KDI | 2007-08-08 | 91 |
| K050952 | HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATOR | KDI | 2006-01-31 | 291 |
| K033505 | RENACLEAN SH DIALYZER CLEANING SYSTEM | LIF | 2004-04-27 | 174 |
| K014016 | ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER | DWC | 2002-02-01 | 58 |
| K991137 | ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER | DTR | 2000-06-08 | 430 |
| K000028 | RENAFLO II HF 2000 HEMOFILTER | KDI | 2000-04-04 | 90 |
| K991851 | RENACLEAR DIALYZER CLEANING SYSTEM | LIF | 1999-08-30 | 90 |
| K983126 | FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS | FIP | 1999-03-08 | 181 |
23 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2010-06-15.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Minntech Corp.?
FDA lists 33 510(k) clearances under the applicant name “Minntech Corp.” (first 1987, latest 2012), across 13 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Minntech Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Minntech Corp. is 103 days.
Which FDA product codes appear under Minntech Corp.?
The most frequent FDA product codes under this applicant name are KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System, 11); DTZ (Oxygenator, Cardiopulmonary Bypass, 4); FIP (Subsystem, Water Purification, 3).
Next steps
- See all 33 Minntech Corp. clearances with predicates and recalls
- Run predicate analysis for product code KDI, Minntech Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.