Cleared Special

K231652 - D100 KIDS

Also marketed or referenced as:
D101 KIDS

K231652 is an FDA 510(k) clearance for D100 KIDS, manufactured by Sorin Group Italia S.R.L.. The device is a Class 2 Cardiovascular device with product code DTZ cleared through the Special 510(k) pathway after a 163-day FDA review.

K231652 · Sorin Group Italia S.R.L. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2023
Decision
163d
Days
Class 2
Risk

K231652 is an FDA 510(k) clearance for the D100 KIDS. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Sorin Group Italia S.R.L. (Mirandola (Modena), IT). The FDA issued a Cleared decision on November 16, 2023 after a review of 163 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4350 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K231652

510(k) Number K231652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2023
Decision Date November 16, 2023
Days to Decision 163 days
Submission Type Special
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
38d slower than avg
Panel avg: 125d · This submission: 163d
Pathway characteristics
Modification to existing cleared device.

DTZ Device Classification - Class 2, Special Controls

Product Code DTZ Oxygenator, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4350
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 - DTZ Oxygenator, Cardiopulmonary Bypass

All 253
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K231652.
Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2
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K231773 · Qura S.R.L · Nov 2023
CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)
K231414 · Chalice Medical , Ltd. · Nov 2023
Affinity Fusion™ Oxygenator System
K230640 · Medtronic, Inc. · Apr 2023
K231652 · D100 KIDS
Download PDF FDA Summary Sorin Group Italia S.…