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Quantum Pump Console

by Spectrum Medical Ltd United Kingdom 510(k)

510(k) K173834 Product code DTQ

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK173834 Date25 May 2018ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

2 recalls · FDA

    • Completed Z-0224-2025 FDA Class II initiated 13 Mar 2023

    The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock.

    • Terminated Z-2238-2019 FDA Class I initiated 29 May 2019

    Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use.

Specification

510(k) · synced 23 Oct 2026

510(k) Number
FDA Product Code
DTQ
FDA applicant
Spectrum Medical , Ltd.
Device Class
Class II
Regulation
21 CFR Part 870.4220
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Other devices from Spectrum Medical Ltd

See all devices from Spectrum Medical Ltd →

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K173834 24 fields · synced 23 Oct 2026