Alaris Medical Infusion System Administration Sets
FDA 510(k) K022209 · Alaris Medical Systems, Inc.
510(k) numberK022209
Submission
- Device name
- Alaris Medical Infusion System Administration Sets
- Applicant
- Alaris Medical Systems, Inc.
San Diego, CA, US - Received
- July 8, 2002
- Decision date
- August 6, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
Other 510(k)s with product code FPA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K043299 | Medley Pca Module, Model 8120MEA · Traditional | 12/10/2004SE |
| K041241 | Medley System with Bar Code Module, Model 8600FRN · Traditional | 07/06/2004SE |
| K031741 | Medley ETCO2 Module (Includes Accessories), Model 8300CCK · Traditional | 02/09/2004SE |
| K032233 | Medley Pca Module, Model 8120MEA · Traditional | 09/09/2003SE |
| K032147 | Signature Edition Infusion Pump, Signature Edition Administration Sets, Models 70XX…FRN · Special | 07/25/2003SE |
| K030459 | Medley System with Medication Management System (MMS)FRN · Traditional | 04/04/2003SE |
| K023264 | Medley Syringe Pump Module System, Model 8110FRN · Traditional | 12/19/2002SE |
| K022677 | Medley SPO2 Module, Model 8210 & SPO2 Sensors & CableDQA · Special | 09/11/2002SE |
| K013087 | Single Dose Dispensing Pin, Model 2201LHI · Traditional | 11/13/2001SE |
| K012383 | Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (Se), Medsystem III…FRN · Traditional | 10/02/2001SE |
Questions and answers
When was Alaris Medical Infusion System Administration Sets cleared by the FDA?
Alaris Medical Infusion System Administration Sets (K022209) received a 510(k) decision of Substantially Equivalent on August 6, 2002, 29 days after the submission was received.
What is the product code of K022209?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.