Safeport Manifold (TM) (or Stopcock)
FDA 510(k) K111016 · Elcam Medical Acal
510(k) numberK111016
Submission
- Device name
- Safeport Manifold (TM) (or Stopcock)
- Applicant
- Elcam Medical Acal
Mp. Merom Hagalil, IL - Received
- April 12, 2011
- Decision date
- June 9, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| 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 |
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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 |
|---|---|---|
| K231900 | A-TAP (previously called Arthrotap)FMF · Special | 07/25/2023SE |
| K211204 | SafePort(TM) Manifold (or Stopcock)FMG · Traditional | 09/15/2022SE |
| K190489 | Elcam Stopcocks and ManifoldsFMG · Special | 04/23/2019SE |
| K141254 | Elcam Stopcocks and ManifoldsFMG · Special | 07/30/2014SE |
| K123084 | Disposable High Pressure Stopcock/Manifold Model HP Stopcock, MP Stopcock, HP Manifold…FMG · Traditional | 05/23/2013SE |
| K120253 | Elcam Vital Signs Wireless System (VSWS)DRG · Traditional | 07/16/2012SE |
| K120624 | Elcam Disposable Integrated Pressure Transducer (Dipt)DRS · Traditional | 06/08/2012SE |
| K111467 | Flexi-Q DV and DVR Auto-InjectorsKZH · Traditional | 02/09/2012SE |
| K100425 | Haskal Torque DeviceDQX · Traditional | 06/17/2010SE |
| K082106 | Elcam Antimicrobial Closed Stopcocks (DSS and TSS)FMG · Special | 10/02/2008SE |
Questions and answers
When was Safeport Manifold (TM) (or Stopcock) cleared by the FDA?
Safeport Manifold (TM) (or Stopcock) (K111016) received a 510(k) decision of Substantially Equivalent on June 9, 2011, 58 days after the submission was received.
What is the product code of K111016?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.