Submission Details
| 510(k) Number | K944750 FDA.gov |
| FDA Decision | Not Cleared PT (PT) |
| Date Received | September 26, 1994 |
| Decision Date | June 19, 1995 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
Not Cleared
Traditional
K944750 - CORFLO 300 PUMP
(FDA 510(k) Clearance)
Jun 1995
Decision
266d
Days
Class 2
Risk
K944750 is an FDA 510(k) submission for the CORFLO 300 PUMP. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Corpak, Inc. (Wheeling, US). The FDA issued a Not Cleared (DENG) decision on June 19, 1995.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
Device Classification
| Product Code | FRN — Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |
Similar Devices — FRN Pump, Infusion
All 847
K252015 · Koru Medical Systems, Inc.
· Jan 2026
K251636 · Baxter Healthcare Corporation
· Jul 2025
K251640 · Baxter Healthcare Corporation
· Jul 2025
K242752 · Iradimed Corporation
· May 2025
K243855 · Carefusion 303, Inc.
· Apr 2025
K242114 · Icu Medical, Inc.
· Apr 2025