HemoSphere Stream Module
FDA 510(k) K253034 · Edwards Lifesciences
510(k) numberK253034
Submission
- Device name
- HemoSphere Stream Module
- Applicant
- Edwards Lifesciences
Irvine, CA, US - Received
- September 22, 2025
- Decision date
- October 21, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQK – Computer, Diagnostic, Programmable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1425
- Specialty
- Cardiovascular
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| K252533 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)DQK · Traditional | 12/18/2025SE |
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| K252364 | Edwards eSheath Optima introducer setDYB · Special | 08/29/2025SE |
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Questions and answers
When was HemoSphere Stream Module cleared by the FDA?
HemoSphere Stream Module (K253034) received a 510(k) decision of Substantially Equivalent on October 21, 2025, 29 days after the submission was received.
What is the product code of K253034?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.