Corflo 300 Pump
FDA 510(k) K944750 · Corpak, Inc.
510(k) numberK944750
Submission
- Device name
- Corflo 300 Pump
- Applicant
- Corpak, Inc.
Wheeling, IL, US - Received
- September 26, 1994
- Decision date
- June 19, 1995
- Decision
- Substantially Equivalent - Subject to Tracking & PMS (PT)
- 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 |
|---|---|---|
| K964514 | Corpak Medsystems Cruz Catheter for Peritoneal DialysisFKO · Traditional | 06/26/1998SE |
| K970178 | Clog Zapper Enteral Feeding Tube Declogging SystemKNT · Traditional | 07/21/1997SE |
| K935512 | Corpak Replacement Gastrostomy Device StomacoreKNT · Traditional | 08/29/1996SE |
| K931921 | Corpak Gastrostomy TubeKNT · Traditional | 06/09/1995SE |
| K932847 | Corpak Enteral PumpFRN · Traditional | 06/17/1994ST |
| K902949 | Corpak Grasping ForcepsOCZ · Traditional | 08/30/1990SE |
| K901501 | Corpak Gastrostomy TubeKGC · Traditional | 06/11/1990SE |
| K882867 | Corpak Percutaneous Endoscopic Gastrostomy TubeKNT · Traditional | 09/21/1988SE |
| K853253 | Corpak Farrell Valve Enteral Gastric Pressure ReliKNT · Traditional | 11/05/1985SE |
| K852792 | Corpak Enteral Sol Adm Pump Set W/ ScrewKNT · Traditional | 08/08/1985SE |
Questions and answers
When was Corflo 300 Pump cleared by the FDA?
Corflo 300 Pump (K944750) received a 510(k) decision of Substantially Equivalent - Subject to Tracking & PMS on June 19, 1995, 266 days after the submission was received.
What is the product code of K944750?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.