Infusable
FDA 510(k) K911216 · Biomedical Dynamics, Inc.
510(k) numberK911216
Submission
- Device name
- Infusable
- Applicant
- Biomedical Dynamics, Inc.
Burnsville, MN, US - Received
- March 19, 1991
- Decision date
- July 22, 1991
- 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 |
| K904484 | Baxter Single Patient Use Pressure InfusorKZD · Traditional | Tecnadyne Scientific, Inc. | 10/26/1990SE |
More from Tecnadyne Scientific, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K915074 | Irrigator/Aspirator ProbeHMX · Traditional | 02/05/1992SE |
| K913751 | Pressure InfuserKZD · Traditional | 01/09/1992SE |
| K911213 | CuffableDXQ · Traditional | 08/07/1991SE |
| K911324 | Irrigation/Aspiration Tubing SetKDH · Traditional | 06/24/1991SE |
| K904376 | Aneroid Blood Pressure GaugeFCY · Traditional | 12/20/1990SE |
| K890268 | Pressure Infusor for I.V. Bags/AutoinflationKPE · Traditional | 05/05/1989SE |
| K881799 | Blood Pressure CuffDXQ · Traditional | 10/14/1988SE |
| K861977 | Biomedical Dynamics Disposable Pressure InfusorKZD · Traditional | 07/15/1986SE |
| K850506 | Correct Flo Intravascular Administration SetFPA · Traditional | 04/01/1985SE |
Questions and answers
When was Infusable cleared by the FDA?
Infusable (K911216) received a 510(k) decision of Substantially Equivalent on July 22, 1991, 125 days after the submission was received.
What is the product code of K911216?
The FDA product code is KZD – Infusor, Pressure, For I.V. Bags, a Class I (low risk) device regulated under 21 CFR 880.5420.