HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM— 510(k) K122813
Substantially EquivalentCincinnati Sub-Zero Products, Inc.
FDA 510(k) clearance K122813 for HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM, Substantially Equivalent on 2012-12-18. Applicant: Cincinnati Sub-Zero Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Cincinnati Sub-Zero Products, Inc.
- Product code
- Code DWC
- Device class
- Class 2
- Regulation
- 21 CFR 870.4250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sharonville, OH, US
Recent devices under product code DWC
view allMore clearances from Cincinnati Sub-Zero Products, Inc.
view all- K123946 — WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETS
- K121669 — WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS)
- K120081 — NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS
- K110104 — BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM
- K101148 — WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS
Adverse events under product code DWC
product code DWC- Death
- 124
- Injury
- 233
- Malfunction
- 3,727
- Total
- 4,084
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K122813
K-number listed on FDA's recall record- Z-2092-2021 — Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during cardiopulmonary bypass procedures
- Z-0825-2019 — Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: The HEMOTHERM¿ Model 400CE Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator / Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass procedures lasting six hours or less. The Hemotherm Dual Reservoir Cooler/Heater may also be used with a hyper / hypothermia blanket under the patient to provide warming through conductive heat transfer.
- Z-0063-2019 — Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm¿ Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator/Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass procedures lasting six hours or less. The Hemotherm Dual Reservoir Cooler/Heater may also be used with a hyper/hypothermia blanket under the patient to provide warming through conductive heat transfer.
- Z-0629-2018 — Hemotherm¿ Dual Reservoir Cooler/Heater System Models 400CE and 400MR Product Usage: A dual reservoir, water re-circulating device that supplies temperature controlled water to a heat exchanger. The device, in conjunction with a heat exchanger, is used to warm or cool the blood that enters and exits a blood heat exchanger for adult, pediatric or infant patients.
- Z-1825-2017 — Hemotherm CE, model 400CE, Heater-Cooling Device
- Z-0654-2017 — The Hemotherm 400CE 115v, containing power board p/n 39945
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K122813.
Data sourced from openFDA. This site is unofficial and independent of the FDA.