Infpump Infiltration Pump
FDA 510(k) K050324 · Carolina Medical, Inc.
510(k) numberK050324
Submission
- Device name
- Infpump Infiltration Pump
- Applicant
- Carolina Medical, Inc.
King, NC, US - Received
- February 9, 2005
- Decision date
- April 27, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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| 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 |
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| K993978 | PR3 Ultrasound SystemIYO · Traditional | 02/10/2000SE |
Questions and answers
When was Infpump Infiltration Pump cleared by the FDA?
Infpump Infiltration Pump (K050324) received a 510(k) decision of Substantially Equivalent on April 27, 2005, 77 days after the submission was received.
What is the product code of K050324?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.