Bodyguard Infusion Pump System
FDA 510(k) K042696 · Caesarea Medical Electronics , Ltd.
510(k) numberK042696
Submission
- Device name
- Bodyguard Infusion Pump System
- Applicant
- Caesarea Medical Electronics , Ltd.
Caesarea, IL - Received
- September 30, 2004
- Decision date
- March 11, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K080954 | T34L Syringe DriverFRN · Special | 05/16/2008SE |
| K070235 | Bodyguard Pain Manager Infusion SystemFRN · Special | 05/18/2007SE |
| K070718 | Modification to: Bodyguard Infusion SystemFRN · Special | 04/13/2007SE |
| K061325 | Bodygaurd Pain Manager Infusion SystemFRN · Abbreviated | 08/24/2006SE |
| K060479 | Modification to Bodyguard Infusion Pump SystemFRN · Traditional | 05/12/2006SE |
| K050800 | Niki T34 and Bodyguard T34 Syringe DriversFRN · Traditional | 11/23/2005SE |
| K040957 | Noa III Enteral Nutrition PumpLZH · Traditional | 05/21/2004SE |
| K031749 | Bodyguard Infusion SystemFRN · Traditional | 08/21/2003SE |
Questions and answers
When was Bodyguard Infusion Pump System cleared by the FDA?
Bodyguard Infusion Pump System (K042696) received a 510(k) decision of Substantially Equivalent on March 11, 2005, 162 days after the submission was received.
What is the product code of K042696?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.