Elcam Stopcocks and Manifolds
FDA 510(k) K190489 · Elcam Medical Acal
510(k) numberK190489
Submission
- Device name
- Elcam Stopcocks and Manifolds
- Applicant
- Elcam Medical Acal
-, IL - Received
- February 28, 2019
- Decision date
- April 23, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMG – Stopcock, I.V. Set
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
Other 510(k)s with product code FMG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242255 | Qitexio® 4-Way Stopcock (QIT014)FMG · Traditional | Medex | 04/29/2025SE |
| K223499 | Three Way Stop CockFMG · Traditional | M/S Romsons International | 07/21/2023SE |
| K223175 | lntravascular Administration Sets with Stopcock and ManifoldFMG · Traditional | Baxter Healthcare Corporation | 03/10/2023SE |
| K211204 | SafePort(TM) Manifold (or Stopcock)FMG · Traditional | Elcam Medical Acal | 09/15/2022SE |
| K210516 | Clicky CrossFMG · Traditional | Yomura Technologies, Inc. | 05/16/2022SE |
| K190539 | TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal…FMG · Traditional | Monumedical, LLC | 10/22/2019SE |
| K172266 | Dynarex Three-Way StopcockFMG · Traditional | Dynarex Corporation | 03/14/2018SE |
| K141254 | Elcam Stopcocks and ManifoldsFMG · Special | Elcam Medical Acal | 07/30/2014SE |
| K123084 | Disposable High Pressure Stopcock/Manifold Model HP Stopcock, MP Stopcock, HP Manifold…FMG · Traditional | Elcam Medical Acal | 05/23/2013SE |
| K130245 | Large Bore Stopcock with Rotating Male Luer Lock/Large Bore Stopcock with Extension Set…FMG · Special | Baxter Healthcare Corp | 03/01/2013SE |
More from Baxter Healthcare Corp
| 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 |
| 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 |
| K111016 | Safeport Manifold (TM) (or Stopcock)FPA · Special | 06/09/2011SE |
| 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 Elcam Stopcocks and Manifolds cleared by the FDA?
Elcam Stopcocks and Manifolds (K190489) received a 510(k) decision of Substantially Equivalent on April 23, 2019, 54 days after the submission was received.
What is the product code of K190489?
The FDA product code is FMG – Stopcock, I.V. Set, a Class II (moderate risk) device regulated under 21 CFR 880.5440.