Entera-Flo Enteral Feeding Pump
FDA 510(k) K894506 · Delmed, Inc.
510(k) numberK894506
Submission
- Device name
- Entera-Flo Enteral Feeding Pump
- Applicant
- Delmed, Inc.
New Brunswick, NJ, US - Received
- July 19, 1989
- Decision date
- August 6, 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
Other 510(k)s with product code FRN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253703 | RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionFRN · Traditional | Deka R&D Corp | 07/24/2026SE |
| K252015 | FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingFRN · Traditional | Koru Medical Systems, Inc. | 01/28/2026SE |
| K251640 | SIGMA Spectrum Infusion Pump with Master Drug LibraryFRN · Traditional | Baxter Healthcare Corporation | 07/28/2025SE |
| K251636 | Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)FRN · Traditional | Baxter Healthcare Corporation | 07/28/2025SE |
| 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 |
|---|---|---|
| K895650 | Enteral Pump Set W/Entera-Flo SpikeKNT · Traditional | 10/02/1990SE |
| K895329 | 600ML and 1200ML Enteral Bag Adm. Set for EnteraKNT · Traditional | 10/02/1990SE |
| K895142 | Enteral Pump Set with Enteral SpikeKNT · Traditional | 10/02/1990SE |
| K901478 | Delmed 80/2 Dialysis System W/Last Bag OptionFKX · Traditional | 07/27/1990SE |
| K901477 | Delmed 80/2 Dialysis System W/UltrafiltrationFKX · Traditional | 07/27/1990SE |
| K900106 | Closed Disconnect SystemKDJ · Traditional | 07/16/1990SE |
| K895933 | Enteral Pump Sets for Use with Ross Flexiflo-IiiKNT · Traditional | 05/02/1990SE |
| K895919 | Enteral Bag Admini. Sets for Use W/Flexiflo-IiiKNT · Traditional | 05/02/1990SE |
| K895696 | Enteral Pump Set W/Enteral Spike for Use W/Feed PuKNT · Traditional | 05/02/1990SE |
| K895330 | 600ML and 1200ML Enteral Bag Adm. Set for FrentaKNT · Traditional | 05/02/1990SE |
Questions and answers
When was Entera-Flo Enteral Feeding Pump cleared by the FDA?
Entera-Flo Enteral Feeding Pump (K894506) received a 510(k) decision of Substantially Equivalent on August 6, 1990, 383 days after the submission was received.
What is the product code of K894506?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.