Submission Details
| 510(k) Number | K152472 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 31, 2015 |
| Decision Date | October 31, 2016 |
| Days to Decision | 427 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Disposable Pressure Transducer
Oct 2016
Decision
427d
Days
Class 2
Risk
About This 510(k) Submission
K152472 is an FDA 510(k) clearance for the Disposable Pressure Transducer, a Transducer, Blood-pressure, Extravascular (Class II — Special Controls, product code DRS), submitted by Zhejiang Haisheng Medical Device Co., Ltd. (Shaoxing, CN). The FDA issued a Cleared decision on October 31, 2016, 427 days after receiving the submission on August 31, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2850.
Device Classification
| Product Code | DRS — Transducer, Blood-pressure, Extravascular |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.2850 |
Manufacturer
Similar Devices — DRS Transducer, Blood-pressure, Extravascular
All 147
K242909 · Edwards Lifesciences, LLC
· Mar 2025
K221782 · Merit Medical Pte. , Ltd.
· Mar 2023
K172458 · Smiths Medical Asd, Inc.
· Nov 2017
K163172 · Smiths Medical Asd, Inc.
· May 2017
K161408 · Centurion Medical Products Corporation
· Nov 2016
K152980 · Edwards Lifesciences, LLC
· Jan 2016