Model 404A I.V. Infusion Pump Analyzer
FDA 510(k) K897096 · Dynatech/Nevada, Inc.
510(k) numberK897096
Submission
- Device name
- Model 404A I.V. Infusion Pump Analyzer
- Applicant
- Dynatech/Nevada, Inc.
Carson City, NV, US - Received
- December 21, 1989
- Decision date
- March 15, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FRN – Pump, Infusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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| K251640 | SIGMA Spectrum Infusion Pump with Master Drug LibraryFRN · Traditional | Baxter Healthcare Corporation | 07/28/2025SE |
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| K242752 | MRidium 3870 MRI Infusion Pump System (3870)FRN · Traditional | Iradimed Corporation | 05/28/2025SE |
| K243855 | BD Alaris Infusion System with Guardrails Suite MXFRN · Traditional | Carefusion 303, Inc. | 04/25/2025SE |
| K242115 | Plum Duo Precision IV PumpFRN · Traditional | Icu Medical, Inc. | 04/02/2025SE |
| K242114 | Plum Solo Precision IV PumpFRN · Traditional | Icu Medical, Inc. | 04/02/2025SE |
| K250357 | RemunityPRO Pump for Remodulin® (treprostinil) InjectionFRN · Special | Deka Research & Development Corp. | 03/11/2025SE |
| K241736 | Remunity 2.0 Pump for Remodulin (treprostinil) InjectionFRN · Traditional | Deka Research and Development Corp. | 01/16/2025SE |
More from Deka Research and Development Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K942546 | Cufflink Non-Invasive Blood Pressure AnalyzerDXN · Traditional | 01/27/1995SE |
| K935817 | Medsim 300 Patient SimulatorDRT · Traditional | 01/18/1994SE |
| K934254 | Impulse 3000 Defibrillator AnalyzerDRL · Traditional | 11/23/1993SE |
| K897074 | Model 215M Patient SimulatorDSI · Traditional | 05/17/1990SE |
| K897029 | Model ECG100 SimulatorDPS · Traditional | 04/26/1990SE |
Questions and answers
When was Model 404A I.V. Infusion Pump Analyzer cleared by the FDA?
Model 404A I.V. Infusion Pump Analyzer (K897096) received a 510(k) decision of Substantially Equivalent on March 15, 1990, 84 days after the submission was received.
What is the product code of K897096?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.