Cleared Traditional

Quantum Heater-Cooler

K212657 · Spectrum Medical , Ltd. · Cardiovascular

May 2022

Decision

256d

Days

Class 2

Risk

About This 510(k) Submission

K212657 is an FDA 510(k) clearance for the Quantum Heater-Cooler, a Controller, Temperature, Cardiopulmonary Bypass (Class II — Special Controls, product code DWC), submitted by Spectrum Medical , Ltd. (Gloucester, GB). The FDA issued a Cleared decision on May 6, 2022, 256 days after receiving the submission on August 23, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4250.

Submission Details

510(k) Number	K212657 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 23, 2021
Decision Date	May 06, 2022
Days to Decision	256 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	DWC — Controller, Temperature, Cardiopulmonary Bypass
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.4250
Definition	If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).