Homepump NSF
FDA 510(k) K932740 · Block Medical, Inc.
510(k) numberK932740
Submission
- Device name
- Homepump NSF
- Applicant
- Block Medical, Inc.
Carlsbad, CA, US - Received
- June 8, 1993
- Decision date
- October 6, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MED – Sterilant, Medical Devices
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6885
- Specialty
- General Hospital
Other 510(k)s with product code MED
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251666 | SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid…MED · Traditional | STERIS Corporation | 04/08/2026SE |
| K232914 | SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid…MED · Special | STERIS Corporation | 10/03/2023SE |
| K230582 | SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900MED · Special | STERIS Corporation | 03/28/2023SE |
| K222615 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical…MED · Special | STERIS Corporation | 09/28/2022SE |
| K211607 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical…MED · Traditional | STERIS Corporation | 09/07/2021SE |
| K210737 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical…MED · Special | STERIS Corporation | 05/12/2021SE |
| K192929 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical…MED · Special | STERIS Corporation | 12/10/2019SE |
| K191343 | SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900MED · Special | STERIS Corporation | 09/05/2019SE |
| K190104 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical…MED · Special | Steris Corporations | 03/22/2019SE |
| K182827 | SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900MED · Traditional | STERIS Corporation | 01/31/2019SE |
More from STERIS Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K944692 | C-Series HomepumpFPA · Traditional | 05/02/1995SE |
| K940117 | MID-500MEB · Traditional | 06/10/1994ST |
| K934551 | Verifuse Ambulatory PumpMEA · Traditional | 03/17/1994SE |
| K935236 | Flow Controlling Extension SetLDR · Traditional | 02/24/1994SE |
| K904663 | Auto Sash (TM)FPA · Traditional | 11/23/1992SE |
| K914924 | Chemo Priming Pin(Tm)FPA · Traditional | 03/06/1992SE |
| K914855 | Multiple Dose ControllerFRN · Traditional | 01/24/1992SE |
| K914854 | ThumperFRN · Traditional | 01/24/1992SE |
| K910695 | Auto Sash (TM)FPA · Traditional | 03/21/1991SE |
| K902891 | Verifuse Ambulatory PumpFRN · Traditional | 11/21/1990SE |
Questions and answers
When was Homepump NSF cleared by the FDA?
Homepump NSF (K932740) received a 510(k) decision of Substantially Equivalent on October 6, 1993, 120 days after the submission was received.
What is the product code of K932740?
The FDA product code is MED – Sterilant, Medical Devices, a Class II (moderate risk) device regulated under 21 CFR 880.6885.