Cleared Traditional

K251783 - Inspire HCR and HCR DUAL cardiotomy reservoirs

K251783 is an FDA 510(k) clearance for Inspire HCR and HCR DUAL cardiotomy res..., manufactured by Sorin Group Italia S.R.L.. The device is a Class 2 Cardiovascular device with product code DTN cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K251783 · Sorin Group Italia S.R.L. · Cardiovascular device
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Dec 2025
Decision
194d
Days
Class 2
Risk

K251783 is an FDA 510(k) clearance for the Inspire HCR and HCR DUAL cardiotomy reservoirs. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Sorin Group Italia S.R.L. (Mirandola (Modena), IT). The FDA issued a Cleared decision on December 22, 2025 after a review of 194 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4400 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Sorin Group Italia S.R.L. devices

FDA 510(k) Submission Details - K251783

510(k) Number K251783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2025
Decision Date December 22, 2025
Days to Decision 194 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 125d · This submission: 194d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTN Device Classification - Class 2, Special Controls

Product Code DTN Reservoir, Blood, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4400
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DTN Reservoir, Blood, Cardiopulmonary Bypass

All 147
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K251783.
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