Steri-Vers
FDA 510(k) K810311 · The Hilrad Co.
510(k) numberK810311
Submission
- Device name
- Steri-Vers
- Applicant
- The Hilrad Co.
Mchenry, IL, US - Received
- February 5, 1981
- Decision date
- April 17, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LDS – Device, Pasteurization, Hot Water
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6991
- Specialty
- General Hospital
Other 510(k)s with product code LDS
| 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 |
Questions and answers
When was Steri-Vers cleared by the FDA?
Steri-Vers (K810311) received a 510(k) decision of Substantially Equivalent on April 17, 1981, 71 days after the submission was received.
What is the product code of K810311?
The FDA product code is LDS – Device, Pasteurization, Hot Water, a Class II (moderate risk) device regulated under 21 CFR 880.6991.