Trantec Physiological Pressure Transduc
FDA 510(k) K840023 · American Bentley
510(k) numberK840023
Submission
- Device name
- Trantec Physiological Pressure Transduc
- Applicant
- American Bentley
Mchenry, IL, US - Received
- January 5, 1984
- Decision date
- June 22, 1984
- 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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|---|---|---|---|
| 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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| K863249 | Oxygenator Model No. BENTLEY-10 PlusDTZ · Traditional | 10/20/1986SE |
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Questions and answers
When was Trantec Physiological Pressure Transduc cleared by the FDA?
Trantec Physiological Pressure Transduc (K840023) received a 510(k) decision of Substantially Equivalent on June 22, 1984, 169 days after the submission was received.
What is the product code of K840023?
The FDA product code is DRS – Transducer, Blood-Pressure, Extravascular, a Class II (moderate risk) device regulated under 21 CFR 870.2850.