Minncare HD
FDA 510(k) K133724 · Medivators, Inc.
510(k) numberK133724
Submission
- Device name
- Minncare HD
- Applicant
- Medivators, Inc.
Minneapolis, MN, US - Received
- December 6, 2013
- Decision date
- August 27, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NIH – Disinfectant, Subsystem, Water Purification
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5665
- Specialty
- Gastroenterology, Urology
Disinfectant intended for reprocessing water purification systems for hemodialysis.
More from Medivators, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K231418 | ENDOGATOR Hybrid Irrigation TubingOCX · Traditional | 08/14/2023SE |
| K223040 | Endo SmartCapFAJ · Special | 03/01/2023SE |
| K213833 | SCOPE BUDDY PLUS Endoscope Flushing AidFEB · Special | 01/14/2022SE |
| K172677 | Advantage Plus Pass-ThruFEB · Traditional | 12/19/2017SE |
| K162128 | Scope Buddy Plus Endoscope Flushing AidFEB · Traditional | 12/21/2016SE |
| K160846 | AmplifEYEFED · Traditional | 07/14/2016SE |
| K152394 | Rapicide PA High-Level Disinfectant Test StripsJOJ · Traditional | 03/11/2016SE |
| K151522 | DEFENDO Bronchoscopy Suction ValveKTI · Traditional | 09/17/2015SE |
| K140753 | Endo Smart Bottle, Rinse and Insufflation SystemOCX · Special | 07/15/2014SE |
| K993042 | Medivators 5 Minute High-Level DisinfectantMED · Traditional | 08/17/2000SE |
Questions and answers
When was Minncare HD cleared by the FDA?
Minncare HD (K133724) received a 510(k) decision of Substantially Equivalent on August 27, 2014, 264 days after the submission was received.
What is the product code of K133724?
The FDA product code is NIH – Disinfectant, Subsystem, Water Purification, a Class II (moderate risk) device regulated under 21 CFR 876.5665.