Disposable Pressure Transducer
FDA 510(k) K152472 · Zhejiang Haisheng Medical Device Co., Ltd.
510(k) numberK152472
Submission
- Device name
- Disposable Pressure Transducer
- Applicant
- Zhejiang Haisheng Medical Device Co., Ltd.
Shaoxing, CN - Received
- August 31, 2015
- Decision date
- October 31, 2016
- 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
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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 |
| 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 |
| K123095 | Medline Blood Pressure TransducerDRS · Abbreviated | Medline Industries, Inc. | 05/08/2013SE |
More from Medline Industries, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K151498 | Breathing circuit bacterial/viral filterCAH · Traditional | 12/18/2015SE |
Questions and answers
When was Disposable Pressure Transducer cleared by the FDA?
Disposable Pressure Transducer (K152472) received a 510(k) decision of Substantially Equivalent on October 31, 2016, 427 days after the submission was received.
What is the product code of K152472?
The FDA product code is DRS – Transducer, Blood-Pressure, Extravascular, a Class II (moderate risk) device regulated under 21 CFR 870.2850.