Primary Solution Set with Universal Spike, Injection Site and Male Luer Lock
FDA 510(k) K011336 · Churchill Medical Systems, Inc.
510(k) numberK011336
Submission
- Device name
- Primary Solution Set with Universal Spike, Injection Site and Male Luer Lock
- Applicant
- Churchill Medical Systems, Inc.
Dover, NH, US - Received
- May 2, 2001
- Decision date
- June 12, 2001
- 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
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| K254123 | Ecomed Disposable Administration SetsFPA · Abbreviated | Ecomed Solutions, LLC | 09/11/2026SE |
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| 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 |
| K013950 | Vented Vial Access DeviceFPA · Traditional | 01/10/2002SE |
| K012157 | Churchill Medical Systems StopcockFMG · Traditional | 09/11/2001SE |
| K011888 | Pressure Activated Check ValveFPA · Traditional | 09/10/2001SE |
| 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 Primary Solution Set with Universal Spike, Injection Site and Male Luer Lock cleared by the FDA?
Primary Solution Set with Universal Spike, Injection Site and Male Luer Lock (K011336) received a 510(k) decision of Substantially Equivalent on June 12, 2001, 41 days after the submission was received.
What is the product code of K011336?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.