Master Flow I.V. Pumpette
FDA 510(k) K905497 · The Master Medical Corp.
510(k) numberK905497
Submission
- Device name
- Master Flow I.V. Pumpette
- Applicant
- The Master Medical Corp.
San Francisco, CA, US - Received
- December 7, 1990
- Decision date
- April 16, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LDR – Controller, Infusion, Intravascular, Electronic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
Other 510(k)s with product code LDR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242693 | DEKA Infusion System, DEKA Administration SetLDR · Special | Deka Research and Development Corporation | 10/07/2024SE |
| K232316 | DEKA Infusion System, DEKA Administration SetLDR · Traditional | Deka Research and Development | 03/01/2024SE |
| K153760 | Volumetric Infusion ControllerLDR · Traditional | DEKA Research & Development | 10/03/2016SE |
| K963136 | Pacer Model 100 Infusion ControllerLDR · Traditional | Health Watch, Inc. | 10/10/1997SE |
| K971865 | Alexander Manufacturing Co. Rechargeable Battery Part Number M12/500-3PLDR · Traditional | Alexander Mfg. Co. | 07/03/1997SE |
| K971826 | Alexander Manufacturing Co. Rechargeable Battery Part Number M12/500LDR · Traditional | Alexander Mfg. Co. | 07/03/1997SE |
| K934543 | Universal Controller, Model 100LDR · Traditional | Metamed, Inc. | 03/29/1994SE |
| K935236 | Flow Controlling Extension SetLDR · Traditional | Block Medical, Inc. | 02/24/1994SE |
| K905498 | Stat 2 IV PumpetteLDR · Traditional | The Master Medical Corp. | 04/16/1991SE |
| K896907 | 3M IV Flow RegulatorLDR · Traditional | 3M Company | 02/26/1990SE |
More from 3M Company
| 510(k) | Device | Decision |
|---|---|---|
| K913076 | I.V. Instant TimerFPA · Traditional | 10/17/1991SE |
| K905498 | Stat 2 IV PumpetteLDR · Traditional | 04/16/1991SE |
| K871753 | Master Medical Device Is I.V. Stat 2FPA · Traditional | 06/05/1987SE |
| K852254 | I.V. Stat MasterFPA · Traditional | 11/18/1985SE |
| K792560 | Master I.V. Dial LockFPA · Traditional | 12/20/1979SE |
Questions and answers
When was Master Flow I.V. Pumpette cleared by the FDA?
Master Flow I.V. Pumpette (K905497) received a 510(k) decision of Substantially Equivalent on April 16, 1991, 130 days after the submission was received.
What is the product code of K905497?
The FDA product code is LDR – Controller, Infusion, Intravascular, Electronic, a Class II (moderate risk) device regulated under 21 CFR 880.5725.