Ez Set Infusion Set
FDA 510(k) K012754 · Animas Corp.
510(k) numberK012754
Submission
- Device name
- Ez Set Infusion Set
- Applicant
- Animas Corp.
Frazer, PA, US - Received
- August 16, 2001
- Decision date
- August 27, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 |
|---|---|---|
| K080639 | Symphony Glucose Management SystemLZG · Traditional | 06/24/2008SE |
| K080587 | Ez Manager Max Diabetes Management SoftwareMRZ · Traditional | 05/15/2008SE |
| K063674 | Ezmanager Max Diabetes Management SoftwareLZG · Traditional | 03/30/2007SE |
| K042873 | Animas Model IR1250 Insulin Infusion PumpLZG · Traditional | 12/10/2004SE |
| K032257 | Model Ir 1200 Insulin PumpLZG · Traditional | 10/16/2003SE |
| K022394 | Ezmanager PlusLZG · Traditional | 06/05/2003SE |
| K021700 | Animus Ezserter Infusion Set InserterKZH · Traditional | 06/04/2002SE |
| K021439 | Model R1000 Ir Insulin Pump, Ezlink Software, Sermon Software, R1000 Ir Download Cradle…LZG · Special | 05/29/2002SE |
| K993184 | R1000 Series Insulin PumpLZG · Traditional | 02/10/2000SE |
Questions and answers
When was Ez Set Infusion Set cleared by the FDA?
Ez Set Infusion Set (K012754) received a 510(k) decision of Substantially Equivalent on August 27, 2001, 11 days after the submission was received.
What is the product code of K012754?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.