Device, Pasteurization, Hot Water
FDA product code LDS · Class II (moderate risk) · 21 CFR 880.6991 · General Hospital
11510(k) clearances
0PMA approvals
11recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K183444 | Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT…LDS · Traditional | Cenorin, LLC | 09/09/2019SE |
| K031799 | Miele Dental Thermal Disinfector, Model G7881LDS · Special | Miele, Inc. | 11/12/2003SE |
| K983068 | Reliance Family of Washer-DisinfectorsLDS · Traditional | STERIS Corporation | 05/31/2000SE |
| K972193 | Olympix Mini-Pasteurmatic (58210)LDS · Traditional | Olympic Medical Corp. | 09/05/1997SE |
| K950518 | Miele G 7781 Dental Thermal DisinfectorLDS · Traditional | Miele Professional | 01/26/1996SE |
| K950566 | Decomat 4656LDS · Traditional | Getinge Disinfection, Inc. | 10/19/1995SE |
| K953645 | Olympic Pasteurmatic SystemLDS · Traditional | Olympic Medical Corp. | 09/22/1995SE |
| K884151 | Model G7731D Washer/Disinfector for Dental Instru.LDS · Traditional | Miele Appliances, Inc. | 05/16/1989SE |
| K860263 | Castle 7538 Floor Loading WasherLDS · Traditional | Castle Co. | 03/05/1986SE |
| K844089 | Castle 7515 Utensil/Glassware WasherLDS · Traditional | Castle Co. | 01/14/1985SE |
| K810311 | Steri-VersLDS · Traditional | The Hilrad Co. | 04/17/1981SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2288-2018 Class II | HLD Systems 600 Series Washer/Pasteurizer, UDI (01) 0085249007009 (11) 160929 (21)…There is a supplier quality issue with the terminal blocks which may cause the terminal block to overheat… | Cenorin, LLC | 04/09/2018Terminated |
| Z-1878-2016 Class II | Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44. Filter Catalogue…The replacement HEPA Filters have been manufactured with sealant that may not be properly cured. Improperly… | Natus Medical Incorporated | 04/22/2016Terminated |
| Z-1729-2014 Class II | HLD Systems Model 610 Washer/High Level Disinfector. Maximum weight of the Model 610…Cenorin LLC is voluntarily recalling HLD Systems Model 610 Washer/High Level Disinfector due to a potential… | Cenorin, LLC | 04/24/2014Terminated |
| Z-1995-2014 Class II | HLD System, Model 610, Medical Device Cleaning and High Level Disinfection…The temperature sensor/control system in the HLD Systems Model 610 may provide a false temperature reading.… | Cenorin, LLC | 01/24/2013Terminated |
| Z-0039-2011 | The Routine Service Kit #082395-00 or Part #030500-00 for HLD SYSTEM and it is labeled…The water level sensor switch in the Medical Device Cleaning and High Level Disinfection Systems… | Cenorin | 06/07/2010Terminated |
| Z-0038-2011 | The HLD SYSTEM 540HT is a Medical Device Cleaning and High Level Disinfection Systems…The water level sensor switch in the Medical Device Cleaning and High Level Disinfection Systems… | Cenorin | 06/07/2010Terminated |
| Z-0037-2011 | HLD SYSTEM 540 is the Medical Device Cleaning and High Level Disinfection Systems…The water level sensor switch in the Medical Device Cleaning and High Level Disinfection Systems… | Cenorin | 06/07/2010Terminated |
| Z-0036-2011 | HLD SYSTEM 520 is a two-tank Medical Device Cleaning and High Level Disinfection Systems…The water level sensor in the Medical Device Cleaning and High Level Disinfection (Washer/Pasteurizer) is… | Cenorin | 06/07/2010Terminated |
| Z-0713-2007 | ThermaSure Medical Device Drying Cabinet, series 1000Potential for user to receive an electrical shock. | Cenorin | 12/21/2006Terminated |
| Z-0712-2007 | ThermaSure Medical Device Drying Cabinet, series 300Potential for user to receive an electrical shock. | Cenorin | 12/21/2006Terminated |
| Z-0711-2007 | ThermaSure Medical Device Drying Cabinet, series 130Potential for user to receive an electrical shock. | Cenorin | 12/21/2006Terminated |