Ivac Ball Valce Admin. Sets
FDA 510(k) K953225 · Y
510(k) numberK953225
Submission
- Device name
- Ivac Ball Valce Admin. Sets
- Applicant
- Y
San Diego, CA, US - Received
- July 10, 1995
- Decision date
- September 27, 1995
- 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 |
|---|---|---|
| K955846 | Model 2082 Temp Plus III Thermometer/Model 2087 Temp Plus III Wall Mount ThermometerFLL · Traditional | 10/01/1996SE |
| K960280 | Ivac Needle Free Valve Administration SetsFPA · Traditional | 04/04/1996SE |
| K934095 | Ivac Vented Syringe Adapter Administration SetsFPA · Traditional | 08/10/1994SE |
| K940897 | Ivac Needleless Infection Valve Administration SetFPA · Traditional | 06/22/1994SE |
| K931550 | Ez Administration SetFPA · Traditional | 01/10/1994SE |
| K932544 | Ivac Space Saver Volumetric Pump, Model 599FRN · Traditional | 10/12/1993SE |
| K931549 | Model EZ-1 Sing CHAN/EZ-2 Dual Channel Infus PumpFRN · Traditional | 10/12/1993SE |
| K922115 | Ivac Needleless Injection ValveFPA · Traditional | 10/12/1993SE |
| K930781 | Infusion PumpFRN · Traditional | 08/19/1993SE |
| K925228 | Ivac 59 Series Universal Set W/ Anti-Free Flow ValFPA · Traditional | 07/30/1993SE |
Questions and answers
When was Ivac Ball Valce Admin. Sets cleared by the FDA?
Ivac Ball Valce Admin. Sets (K953225) received a 510(k) decision of Substantially Equivalent on September 27, 1995, 79 days after the submission was received.
What is the product code of K953225?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.