DRS — Transducer, Blood-Pressure, Extravascular Class II
FDA product code DRS covers "Transducer, Blood-Pressure, Extravascular", a Class II medical device regulated under 21 CFR 870.2850. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DRS
- Device Class
- Class II
- Regulation Number
- 870.2850
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K242909 | edwards lifesciences | FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors | March 21, 2025 |
| K221782 | merit medical pte. | Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes | March 17, 2023 |
| K172458 | smiths medical asd | HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw | November 9, 2017 |
| K163172 | smiths medical asd | HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw | May 24, 2017 |
| K161408 | centurion medical products corporation | Compass Cast and MAP | November 22, 2016 |
| K152472 | zhejiang haisheng medical device co | Disposable Pressure Transducer | October 31, 2016 |
| K152980 | edwards lifesciences | Flo Trac sensor, Volume View sensor | January 19, 2016 |
| K151040 | biometrix | Art-line Single channel blood pressure system, Art-line Double channel blood pre | September 4, 2015 |
| K133624 | mirador biomedical | COMPASS CT, COMPASS CT PORT | April 18, 2014 |
| K123095 | medline industries | MEDLINE BLOOD PRESSURE TRANSDUCER | May 8, 2013 |
| K120624 | elcam medical acal | ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT) | June 8, 2012 |
| K112203 | mirador biomedical | COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSU | December 14, 2011 |
| K102033 | b.braun melsungen | COMBITRANS MONITORING SETS AND ACCESSORIES | April 7, 2011 |
| K103715 | mirador biomedical | COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE | January 20, 2011 |
| K101189 | reavillmed | REAVILLMED PRESSURE MONITORING SYSTEM AND PICC | December 22, 2010 |
| K101518 | mirador biomedical | COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE | October 13, 2010 |
| K092644 | terumo cardiovascular systems | TERUMO PRESSURE ISOLATOR | December 10, 2009 |
| K091408 | shenzhen ant hi-tech industrial co | DISPOSABLE PRESSURE TRANSDUCER | August 18, 2009 |
| K070710 | biosensors international-usa | ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM | April 19, 2007 |
| K062342 | sentra medical devices | TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT | September 25, 2006 |