Elcam Disposable Integrated Pressure Transducer (Dipt)
FDA 510(k) K120624 · Elcam Medical Acal
510(k) numberK120624
Submission
- Device name
- Elcam Disposable Integrated Pressure Transducer (Dipt)
- Applicant
- Elcam Medical Acal
Kibbutz Baram, IL - Received
- March 1, 2012
- Decision date
- June 8, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRS – Transducer, Blood-Pressure, Extravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2850
- Specialty
- Cardiovascular
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254074 | TruPressDRS · Traditional | Procerus Enterprises | 09/10/2026SE |
| K242909 | FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsDRS · Special | Edwards Lifesciences, LLC | 03/21/2025SE |
| K221782 | Meritrans ECO Reusable Pressure Transducer, Meritrans ECO DomesDRS · Traditional | Merit Medical Pte. , Ltd. | 03/17/2023SE |
| K172458 | HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus…DRS · Traditional | Smiths Medical Asd, Inc. | 11/09/2017SE |
| K163172 | HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus…DRS · Traditional | Smiths Medical Asd, Inc. | 05/24/2017SE |
| K161408 | Compass Cast and MAPDRS · Traditional | Centurion Medical Products Corporation | 11/22/2016SE |
| K152472 | Disposable Pressure TransducerDRS · Traditional | Zhejiang Haisheng Medical Device Co., Ltd. | 10/31/2016SE |
| K152980 | Flo Trac sensor, Volume View sensorDRS · Traditional | Edwards Lifesciences, LLC | 01/19/2016SE |
| K151040 | Art-line Single channel blood pressure system, Art-line Double channel blood pressure…DRS · Traditional | Biometrix , Ltd. | 09/04/2015SE |
| K133624 | Compass CT, Compass CT PortDRS · Traditional | Mirador Biomedical | 04/18/2014SE |
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| 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 |
| 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 Disposable Integrated Pressure Transducer (Dipt) cleared by the FDA?
Elcam Disposable Integrated Pressure Transducer (Dipt) (K120624) received a 510(k) decision of Substantially Equivalent on June 8, 2012, 99 days after the submission was received.
What is the product code of K120624?
The FDA product code is DRS – Transducer, Blood-Pressure, Extravascular, a Class II (moderate risk) device regulated under 21 CFR 870.2850.