Cormed II Ambulatory Infusion Pump
FDA 510(k) K850674 · Cormed, Inc., Sub. C.R.Bard, Inc.
510(k) numberK850674
Submission
- Device name
- Cormed II Ambulatory Infusion Pump
- Applicant
- Cormed, Inc., Sub. C.R.Bard, Inc.
Medina, NY, US - Received
- February 20, 1985
- Decision date
- April 9, 1985
- 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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| K242752 | MRidium 3870 MRI Infusion Pump System (3870)FRN · Traditional | Iradimed Corporation | 05/28/2025SE |
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| 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 |
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| K843083 | Cormed Huber Point NeedleGAA · Traditional | 09/05/1984SE |
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Questions and answers
When was Cormed II Ambulatory Infusion Pump cleared by the FDA?
Cormed II Ambulatory Infusion Pump (K850674) received a 510(k) decision of Substantially Equivalent on April 9, 1985, 48 days after the submission was received.
What is the product code of K850674?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.