Verifuse Ambulatory Pump
FDA 510(k) K902891 · Block Medical, Inc.
510(k) numberK902891
Submission
- Device name
- Verifuse Ambulatory Pump
- Applicant
- Block Medical, Inc.
Carlsbad, CA, US - Received
- July 2, 1990
- Decision date
- November 21, 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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| K253703 | RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionFRN · Traditional | Deka R&D Corp | 07/24/2026SE |
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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 |
|---|---|---|
| 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 |
| K932740 | Homepump NSFMED · Traditional | 10/06/1993SE |
| 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 |
Questions and answers
When was Verifuse Ambulatory Pump cleared by the FDA?
Verifuse Ambulatory Pump (K902891) received a 510(k) decision of Substantially Equivalent on November 21, 1990, 142 days after the submission was received.
What is the product code of K902891?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.