Repeater Pump II Tube Sets
FDA 510(k) K062909 · Baxa Corp.
510(k) numberK062909
Submission
- Device name
- Repeater Pump II Tube Sets
- Applicant
- Baxa Corp.
Englewood, CO, US - Received
- September 27, 2006
- Decision date
- March 9, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FPA – Set, Administration, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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|---|---|---|---|
| K254123 | Ecomed Disposable Administration SetsFPA · Abbreviated | Ecomed Solutions, LLC | 09/11/2026SE |
| K261530 | iiSure Infusion SetFPA · Special | Deka Research and Development | 06/03/2026SE |
| K252543 | AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072…FPA · Traditional | Amsino International, Inc. | 05/04/2026SE |
| K251375 | PuraCath Firefly Needleless Connector IT (9005)FPA · Traditional | Puracath Medical, Inc. | 02/12/2026SE |
| K251257 | nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free…FPA · Traditional | Np Medical | 12/04/2025SE |
| K250325 | BD Alaris Pump Infusion SetFPA · Traditional | Carefusion (Bd) | 10/30/2025SE |
| K251814 | EZ IV Administration SetFPA · Traditional | Epic Medical Pte. , Ltd. | 08/29/2025SE |
| K251854 | SteadiSet infusion setFPA · Abbreviated | Tandem Diabetes Care | 08/06/2025SE |
| K243841 | Sparta Infusion Set for InsulinFPA · Traditional | Deka Research and Development | 08/01/2025SE |
| K243392 | Infusomat® Space Volumetric Infusion Pump Administration SetsFPA · Traditional | B.Braun Medical, Inc. | 07/24/2025SE |
More from B.Braun Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K090917 | Sureconnect Closed Drug Reconstitution and Transfer SystemLHI · Traditional | 02/19/2010SE |
| K070163 | Swabbable Cap, Model 60205ODI · Traditional | 08/03/2007SE |
| K022523 | Rapid-Fill Tubeset, Model 90005LHI · Traditional | 08/12/2002SE |
| K002705 | Exacta-Mix 2400 Compounding System, Model Exacta-Mix 2400LHI · Traditional | 03/28/2001SE |
| K983321 | Microfuse Dual Rate InfuserFRN · Special | 10/06/1998SE |
| K951871 | Piston SyringeFMF · Traditional | 06/21/1995SE |
| K933506 | Syringe InfuserFRN · Traditional | 02/25/1994SE |
Questions and answers
When was Repeater Pump II Tube Sets cleared by the FDA?
Repeater Pump II Tube Sets (K062909) received a 510(k) decision of Substantially Equivalent on March 9, 2007, 163 days after the submission was received.
What is the product code of K062909?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.