Accupro Enteral Feeding Pump
FDA 510(k) K841729 · American Mcgaw
510(k) numberK841729
Submission
- Device name
- Accupro Enteral Feeding Pump
- Applicant
- American Mcgaw
Mchenry, IL, US - Received
- April 25, 1984
- Decision date
- June 1, 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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| 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 |
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| 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 |
|---|---|---|
| K853549 | Mcgaw/Drop Watch Flow MonitorFLN · Traditional | 11/12/1985SE |
| K843639 | Add-A-Vial Solution Transfer DeviceLHI · Traditional | 01/14/1985SE |
| K843954 | Mixing ContainerKPE · Traditional | 11/28/1984SE |
| K840388 | Pab IV ContainerKPE · Traditional | 03/06/1984SE |
| K840212 | Concentrated Platelet Admin. SetFPA · Traditional | 03/06/1984SE |
| K831716 | Capd - Catheter AdapterFKX · Traditional | 06/24/1983SE |
| K822240 | Ethylene Oxide Steriliz. Parametric Rel.KFX · Traditional | 12/30/1982SE |
| K820133 | Mcgaw Fat Emulsion SetFPA · Traditional | 04/06/1982SE |
| K813092 | Accupro I.V. Administration SetFPA · Traditional | 12/31/1981SE |
| K810683 | Capd Catheter AdapterFKX · Traditional | 05/08/1981SE |
Questions and answers
When was Accupro Enteral Feeding Pump cleared by the FDA?
Accupro Enteral Feeding Pump (K841729) received a 510(k) decision of Substantially Equivalent on June 1, 1984, 37 days after the submission was received.
What is the product code of K841729?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.