MX820-5 Pressure Infusor 500CC MX820-10
FDA 510(k) K800560 · Medex, Inc.
510(k) numberK800560
Submission
- Device name
- MX820-5 Pressure Infusor 500CC MX820-10
- Applicant
- Medex, Inc.
Walker, MI, US - Received
- March 12, 1980
- Decision date
- April 29, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KZD – Infusor, Pressure, For I.V. Bags
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5420
- Specialty
- General Hospital
Other 510(k)s with product code KZD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K974074 | Infusion Dynamics Power InfuserKZD · Traditional | Infusion Dynamics, Inc. | 02/17/1998SE |
| K973843 | Msi Pressure InfusorKZD · Traditional | Smith Assoc. | 10/29/1997SE |
| K953290 | Olympus Automatic Surgical Irrigation PumpKZD · Traditional | Olympus America, Inc. | 10/07/1995SE |
| K951988 | PressurizerKZD · Traditional | Promedic, Inc. | 06/14/1995SE |
| K942933 | Pressure Infusion CuffKZD · Traditional | Circulatory Technology, Inc. | 08/25/1994SE |
| K930012 | Kawasumi Laboratories K-CuffKZD · Traditional | Kawasumi Laboratories Co., Ltd. | 12/14/1993SE |
| K921168 | Allen Infusion Pump Model 3000 and Irrigation 2000KZD · Traditional | Allen Medical Systems, Inc. | 04/21/1993SE |
| K913751 | Pressure InfuserKZD · Traditional | Biomedical Dynamics, Inc. | 01/09/1992SE |
| K910926 | Tecnadyne Surgi-Squeeze Infusion PumpKZD · Traditional | Tecnadyne Scientific, Inc. | 08/02/1991SE |
| K911216 | InfusableKZD · Traditional | Biomedical Dynamics, Inc. | 07/22/1991SE |
More from Biomedical Dynamics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K242255 | Qitexio® 4-Way Stopcock (QIT014)FMG · Traditional | 04/29/2025SE |
| K203738 | QitexioFMF · Traditional | 03/14/2022SE |
| K042432 | Pharmguard Toolbox, Model G6000782FRN · Traditional | 01/04/2005SE |
| K040899 | Medex 3000 Series MR Syringe Infusion PumpFRN · Traditional | 04/30/2004SE |
| K020780 | Transtar Intracranial Pressure Transducer, Model MX950ICPGWM · Abbreviated | 05/20/2002SE |
| K000328 | Medex 3000 Series MRI Compatible Syringe Infusion PumpFRN · Traditional | 05/09/2000SE |
| K982640 | Medex 3000 Series Syringe Infusion PumpFRN · Traditional | 04/06/1999ST |
| K982123 | Contrast Control DeviceFPA · Traditional | 07/21/1998SE |
| K955231 | Medfusion Model 2001 Syringe Infusion PumpFRN · Traditional | 07/18/1996ST |
| K961404 | MX960 Reusable Pressure TransducerDRS · Traditional | 06/27/1996SE |
Questions and answers
When was MX820-5 Pressure Infusor 500CC MX820-10 cleared by the FDA?
MX820-5 Pressure Infusor 500CC MX820-10 (K800560) received a 510(k) decision of Substantially Equivalent on April 29, 1980, 48 days after the submission was received.
What is the product code of K800560?
The FDA product code is KZD – Infusor, Pressure, For I.V. Bags, a Class I (low risk) device regulated under 21 CFR 880.5420.