Simplicity Simplex Soft Infusion Set
FDA 510(k) K020629 · Sterling Medivations, Inc.
510(k) numberK020629
Submission
- Device name
- Simplicity Simplex Soft Infusion Set
- Applicant
- Sterling Medivations, Inc.
Los Altos Hills, CA, US - Received
- February 26, 2002
- Decision date
- April 1, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K021530 | Simplicity Easy P Soft Infusion Set for Infusion And/Or Injection of Fluids Into the…FPA · Abbreviated | 05/21/2002SE |
| K021487 | Simplicity Easy Access P Infusion SetFPA · Abbreviated | 05/17/2002SE |
| K021296 | Simplicity QD Easy P Infusion SetFPA · Abbreviated | 05/14/2002SE |
| K021216 | Simplicty Simplex P Infusion Set for Use with the Minimed Paradigm Infusion PumpsFPA · Abbreviated | 05/03/2002SE |
| K021005 | Simplicity Easy Access II Infusion Set for Infusion And/Or Injection of Fluids Into the…FPA · Abbreviated | 04/25/2002SE |
| K020990 | Simplicity Soft QD II Infusion Set for Infusion And/Or Injection of Fluids Into the Body…FPA · Special | 04/10/2002SE |
| K020912 | Simplicity Easy Soft Infusion SetFPA · Abbreviated | 04/10/2002SE |
| K014062 | Simplicity Easy Access Infusion SetFPA · Abbreviated | 01/17/2002SE |
| K014061 | Simplicity Starplus Soft Infusion SetFPA · Abbreviated | 01/17/2002SE |
| K013767 | Simplicity Infusion Reservoir for Use to Infuse Medicine, Including Insulin, From an…FRN · Traditional | 12/12/2001SE |
Questions and answers
When was Simplicity Simplex Soft Infusion Set cleared by the FDA?
Simplicity Simplex Soft Infusion Set (K020629) received a 510(k) decision of Substantially Equivalent on April 1, 2002, 34 days after the submission was received.
What is the product code of K020629?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.