Cadd Administration Set
FDA 510(k) K991599 · Sims Deltec, Inc.
510(k) numberK991599
Submission
- Device name
- Cadd Administration Set
- Applicant
- Sims Deltec, Inc.
St. Paul, MN, US - Received
- May 10, 1999
- Decision date
- June 15, 1999
- 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
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 |
|---|---|---|
| K010426 | Proport Plastic Venous Implantable Access Systems Pre-Assembled with Silicone CatheterLJT · Traditional | 03/08/2001SE |
| K000842 | Cadd-Prizm PCS II Model 6101 Ambulatory Infusion SystemFRN · Traditional | 06/08/2000SE |
| K000942 | Cadd Checkvalve Administration Set, Model 21-7090FPA · Traditional | 04/27/2000SE |
| K994216 | Plastic Port Implantable Venous Access SystemLJT · Traditional | 01/27/2000SE |
| K992697 | Port-A-Cath II Trans-Arterial Percutaneous SystemLJT · Traditional | 11/18/1999SE |
| K992880 | P.A.S. Port Elite Implantable Venous Access SystemLJT · Traditional | 10/19/1999SE |
| K991301 | Cadd-Prizm High Volume Administration Set with 1.2 U Filter and Add-On Anti-Siphon…FPA · Traditional | 06/09/1999SE |
| K991255 | Cadd-Tpn Administration Set, Model 21-7071FPA · Traditional | 06/09/1999SE |
| K990083 | Cadd Administration Set, Cadd 250ML Flexible Medication Reservoir, Modified Securit…FPA · Traditional | 02/12/1999SE |
| K984055 | Clinicath Polyflow Polyurethane Peripherally Inserted CathetersFOZ · Traditional | 01/29/1999SE |
Questions and answers
When was Cadd Administration Set cleared by the FDA?
Cadd Administration Set (K991599) received a 510(k) decision of Substantially Equivalent on June 15, 1999, 36 days after the submission was received.
What is the product code of K991599?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.