MEDI-TRACE DISPOSABLE DOMES/MONITORING
FDA 510(k) clearance K800706 · decided 1980-04-16
Clearance details
- K-number
- K800706
- Device name
- MEDI-TRACE DISPOSABLE DOMES/MONITORING
- Applicant
- Graphic Controls Corp.
- Decision
- Substantially Equivalent
- Date received
- 1980-03-31
- Decision date
- 1980-04-16
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- DRS
- Device class
- 2
- Regulation number
- 870.2850
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors (K242909) | Edwards Lifesciences, LLC | 2025-03-21 |
| Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes (K221782) | Merit Medical Pte. , Ltd. | 2023-03-17 |
| HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit (K172458) | Smiths Medical Asd, Inc. | 2017-11-09 |
| HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit (K163172) | Smiths Medical Asd, Inc. | 2017-05-24 |
| Compass Cast and MAP (K161408) | Centurion Medical Products Corporation | 2016-11-22 |
| Disposable Pressure Transducer (K152472) | Zhejiang Haisheng Medical Device Co., Ltd. | 2016-10-31 |
| Flo Trac sensor, Volume View sensor (K152980) | Edwards Lifesciences, LLC | 2016-01-19 |
| Art-line Single channel blood pressure system, Art-line Double channel blood pressure system, Art-line Triple channel blood pressure system, IAP Monitoring Set with Disposable Transducer (K151040) | Biometrix , Ltd. | 2015-09-04 |
| COMPASS CT, COMPASS CT PORT (K133624) | Mirador Biomedical | 2014-04-18 |
| MEDLINE BLOOD PRESSURE TRANSDUCER (K123095) | Medline Industries, Inc. | 2013-05-08 |
| ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT) (K120624) | Elcam Medical Acal | 2012-06-08 |
| COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSIST (K112203) | Mirador Biomedical, Inc. | 2011-12-14 |
Recalls involving this device
No recalls on record reference this clearance.