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Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)

by Quara S.R.L.

510(k) K223879

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

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 · Special NumberK223879 Date13 Apr 2023ClearedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-3327-2026 FDA Class II initiated 17 Jul 2026
    • Ongoing Z-3328-2026 FDA Class II initiated 17 Jul 2026

    Due to blood-to-glycol leak in the heat exchanger.

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  • Withdrawn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
DTR
Device Class
Class II
Regulation
21 CFR Part 870.4240
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent