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Affinity Pixie Oxygenation System with Carmeda Bioactive Surface or Balance Biosurface

by Medtronic, Inc.

510(k) K100645

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK100645 Date14 Sep 2012ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DTZ
Device Class
Class II
Regulation
21 CFR Part 870.4350
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Affinity Pixie Oxygenation System with Carmeda Bioactive Surface or Balance Biosurface is an oxygenator for cardiopulmonary bypass. It is designed to manage blood flow for neonates, infants, and small pediatric patients during cardiac surgery.

The system is supplied as a single-use device and includes the Affinity Orbit™ Holder System for flexible circuit positioning. It is authorized under FDA 510(k) clearance K100645 with product code DTZ and regulation number 870.4350, classified as a Class II cardiovascular device.

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Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Affinity Pixie Oxygenation System used for?

    The Affinity Pixie Oxygenation System is used to manage blood flow during cardiopulmonary bypass in neonates, infants, and small pediatric patients undergoing cardiac surgery, providing oxygenation and carbon dioxide removal as part of the extracorporeal circuit.

  • Is the Affinity Pixie Oxygenation System supplied sterile and for single use only?

    Yes, the system is supplied as a single-use device and is intended for one-time use only; it is provided sterile and should not be reprocessed or reused due to risks of contamination, material degradation, and compromised performance.

  • What components are included with the Affinity Pixie Oxygenation System?

    The system includes the oxygenator with either Carmeda Bioactive Surface or Balance Biosurface and the Affinity Orbit™ Holder System, which allows for flexible positioning of the circuit during setup and use in the operating room.

  • What regulatory pathway was used for the Affinity Pixie Oxygenation System?

    The Affinity Pixie Oxygenation System received marketing authorization through the FDA 510(k) clearance process under submission K100645, with product code DTZ and regulation number 870.4350, and is classified as a Class II cardiovascular device.