Compass CT, Compass CT Port
FDA 510(k) K133624 · Mirador Biomedical
510(k) numberK133624
Submission
- Device name
- Compass CT, Compass CT Port
- Applicant
- Mirador Biomedical
Seattle, WA, US - Received
- November 26, 2013
- Decision date
- April 18, 2014
- 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
Other 510(k)s with product code DRS
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|---|---|---|---|
| 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 |
| K123095 | Medline Blood Pressure TransducerDRS · Abbreviated | Medline Industries, Inc. | 05/08/2013SE |
More from Medline Industries, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K112203 | Compass Global Pressure, Compass Thoracentesis, Paracentesis, Compartment Pressure…DRS · Traditional | 12/14/2011SE |
| K103715 | Compass Vascular Access / Access Port / Lumbar Puncture / Intracranial PressureDRS · Special | 01/20/2011SE |
| K101518 | Compass Vascular Access; Compass Lumbar PunctureDRS · Traditional | 10/13/2010SE |
Questions and answers
When was Compass CT, Compass CT Port cleared by the FDA?
Compass CT, Compass CT Port (K133624) received a 510(k) decision of Substantially Equivalent on April 18, 2014, 143 days after the submission was received.
What is the product code of K133624?
The FDA product code is DRS – Transducer, Blood-Pressure, Extravascular, a Class II (moderate risk) device regulated under 21 CFR 870.2850.