Vented Vial Access Device
FDA 510(k) K013950 · Churchill Medical Systems, Inc.
510(k) numberK013950
Submission
- Device name
- Vented Vial Access Device
- Applicant
- Churchill Medical Systems, Inc.
Dover, NH, US - Received
- November 30, 2001
- Decision date
- January 10, 2002
- 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 |
|---|---|---|
| K041038 | Churchill Medical Dual Chamber Empty ContainerKPE · Abbreviated | 12/21/2004SE |
| K021395 | Modification to 30 Extension SetFPA · Special | 05/13/2002SE |
| K013949 | Universal Vial Access Spike with Needleless ConnectorFPA · Traditional | 03/27/2002SE |
| K020544 | Wing Safe Infusion Set 20 Ga, SHS2000 Series; Wing Safe Infusion Set 19 Ga, SHS1900…FPA · Special | 03/12/2002SE |
| K012157 | Churchill Medical Systems StopcockFMG · Traditional | 09/11/2001SE |
| K011888 | Pressure Activated Check ValveFPA · Traditional | 09/10/2001SE |
| K011336 | Primary Solution Set with Universal Spike, Injection Site and Male Luer LockFPA · Traditional | 06/12/2001SE |
| K896333 | CMS IV FiltersFPB · Traditional | 01/11/1990SE |
| K894954 | .22 & 1.2 Micron IV FiltersFPB · Traditional | 11/13/1989SE |
| K884370 | CMS IV Extension SetsFPK · Traditional | 11/07/1988SE |
Questions and answers
When was Vented Vial Access Device cleared by the FDA?
Vented Vial Access Device (K013950) received a 510(k) decision of Substantially Equivalent on January 10, 2002, 41 days after the submission was received.
What is the product code of K013950?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.