Lockbox for Use with Cadd Solis Infusion Pump
FDA 510(k) K080743 · Smiths Medical MD, Inc.
510(k) numberK080743
Submission
- Device name
- Lockbox for Use with Cadd Solis Infusion Pump
- Applicant
- Smiths Medical MD, Inc.
St. Paul, MN, US - Received
- March 17, 2008
- Decision date
- April 25, 2008
- 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
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 |
|---|---|---|
| K112407 | Smith Medical Peel-Away Sheath IntroducersDYB · Traditional | 02/09/2012SE |
| K111386 | Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication Safety…FRN · Traditional | 08/29/2011SE |
| K101180 | Gripper Micro Blunt Cannula, Non-Coring Safety Needle (Gripper Micro Needle) Model:…FPA · Traditional | 08/03/2010SE |
| K091181 | Lockbox for Use with Medfusion 3000 Series PumpsMRZ · Traditional | 06/12/2009SE |
| K082783 | Cadd -Solis Medication Safety Software: Administrator and Point-Of-CareMRZ · Traditional | 12/17/2008SE |
| K081156 | Cadd Medication Cassette ReservoirFPA · Traditional | 07/18/2008SE |
| K072144 | Cadd -Solis Ambulatory Infusion Pump and Cadd -Solis Medication Safety Software -…MEA · Traditional | 03/07/2008SE |
| K072955 | Cadd-Sentry Pro Medication Safety Software-Administrator (21-6275), Point of Care…MRZ · Traditional | 02/13/2008SE |
| K072657 | Power Port-A-Cath, Cath II, and P.A.S. Port T2 Power P.A.C. Implantable Venous Access…LJT · Traditional | 12/14/2007SE |
| K072059 | Gripper Micro NeedleFMI · Traditional | 11/01/2007SE |
Questions and answers
When was Lockbox for Use with Cadd Solis Infusion Pump cleared by the FDA?
Lockbox for Use with Cadd Solis Infusion Pump (K080743) received a 510(k) decision of Substantially Equivalent on April 25, 2008, 39 days after the submission was received.
What is the product code of K080743?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.