Inspire HCR and HCR DUAL cardiotomy reservoirs
FDA 510(k) K251783 · Sorin Group Italia S.R.L.
510(k) numberK251783
Submission
- Device name
- Inspire HCR and HCR DUAL cardiotomy reservoirs
- Applicant
- Sorin Group Italia S.R.L.
Mirandola (Modena), IT - Received
- June 11, 2025
- Decision date
- December 22, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DTN – Reservoir, Blood, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4400
- Specialty
- Cardiovascular
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| K151110 | Intersept Filtered Cardiotomy ReservoirDTN · Special | Medtronic, Inc. | 05/27/2015SE |
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| K141233 | Affinity Pixie Oxygenation System with; Carmeda Bioactive Surface, Balance BiosufaceDTN · Special | Medtronic, Inc. | 06/12/2014SE |
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Questions and answers
When was Inspire HCR and HCR DUAL cardiotomy reservoirs cleared by the FDA?
Inspire HCR and HCR DUAL cardiotomy reservoirs (K251783) received a 510(k) decision of Substantially Equivalent on December 22, 2025, 194 days after the submission was received.
What is the product code of K251783?
The FDA product code is DTN – Reservoir, Blood, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4400.