Monitoring, Pressure Kit
FDA 510(k) K781680 · Pharmaseal Div., Baxter Healthcare Corp.
510(k) numberK781680
Submission
- Device name
- Monitoring, Pressure Kit
- Applicant
- Pharmaseal Div., Baxter Healthcare Corp.
Mchenry, IL, US - Received
- October 2, 1978
- Decision date
- October 6, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| 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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|---|---|---|
| K792369 | Hyperalimentation Dressing TrayFRG · Traditional | 12/10/1979SE |
| K792141 | Continuous Flush DeviceKRA · Traditional | 12/05/1979SE |
| K792019 | Phadecode Xa Inhibitor AssayJBQ · Traditional | 11/05/1979SE |
| K791773 | Ventilator Tube with FilterCAH · Traditional | 10/22/1979SE |
| K791156 | Amipaque Myelogram TrayFMI · Traditional | 07/30/1979SE |
| K790896 | Two-Way Anesthesia FilterCAH · Traditional | 06/05/1979SE |
| K790409 | Low Dead Space Insulin SyringeFMF · Traditional | 04/24/1979SE |
| K782069 | Tray, Auxillary BlockCAZ · Traditional | 01/04/1979SE |
| K781797 | Prep Tray, Preoperative SkinOJU · Traditional | 11/08/1978SE |
| K780887 | Improved Disposable Hypodermic NeedleGAA · Traditional | 06/22/1978SE |
Questions and answers
When was Monitoring, Pressure Kit cleared by the FDA?
Monitoring, Pressure Kit (K781680) received a 510(k) decision of Substantially Equivalent on October 6, 1978, 4 days after the submission was received.
What is the product code of K781680?
The FDA product code is DRS – Transducer, Blood-Pressure, Extravascular, a Class II (moderate risk) device regulated under 21 CFR 870.2850.