Enteral Nutrition Pump
FDA 510(k) K841630 · Superior Plastic Products Corp.
510(k) numberK841630
Submission
- Device name
- Enteral Nutrition Pump
- Applicant
- Superior Plastic Products Corp.
Mchenry, IL, US - Received
- April 19, 1984
- Decision date
- June 7, 1984
- 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 |
| 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 |
|---|---|---|
| K851981 | No. 5300-3 1/2 French Umbilical Vessel Cath. Etc.FOZ · Traditional | 06/18/1985SE |
| K843975 | 9 French 42LONG Polyurethane Graduated Enteric FeKNT · Traditional | 11/20/1984SE |
| K841945 | Enteral Feeding BottleKNT · Traditional | 07/26/1984SE |
| K841480 | Infection Control ValveBSY · Traditional | 04/25/1984SE |
| K840324 | Silicone Sump Drain 20 & 40 FrenchJCY · Traditional | 04/25/1984SE |
| K840323 | Silicone Suction & Irrigation DrainGBX · Traditional | 04/25/1984SE |
| K833687 | Dispos. Enteric Feeding Tubes W/Safe-TKNT · Traditional | 03/02/1984SE |
| K833947 | Superior Enternal Feeding SystemKNT · Traditional | 02/04/1984SE |
| K820460 | 3.5 & 5.5 Oz. Sodium Chloride SolutionJOL · Traditional | 03/08/1982SE |
| K812312 | Sterile Water 4OZ.JOL · Traditional | 11/13/1981SE |
Questions and answers
When was Enteral Nutrition Pump cleared by the FDA?
Enteral Nutrition Pump (K841630) received a 510(k) decision of Substantially Equivalent on June 7, 1984, 49 days after the submission was received.
What is the product code of K841630?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.