Bio-Cal 370 Heater/Cooler
FDA 510(k) K894980 · Bio Medicus, Inc.
510(k) numberK894980
Submission
- Device name
- Bio-Cal 370 Heater/Cooler
- Applicant
- Bio Medicus, Inc.
Eden Prairie, MN, US - Received
- August 8, 1989
- Decision date
- November 2, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DWJ – System, Thermal Regulating
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5900
- Specialty
- Cardiovascular
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).
Other 510(k)s with product code DWJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262089 | Disposable Warming BlanketDWJ · Traditional | Hangzhou Tappa Medical Technology Co., Ltd. | 08/21/2026SE |
| K261437 | Mistral-Air® Warming SystemDWJ · Special | The Surgical Company International B.V., doing… | 08/07/2026SE |
| K260278 | ThermAffyx(TM) Patient Safety SystemDWJ · Traditional | Stihler Electronic GmbH | 07/08/2026SE |
| K260903 | Hot Pink Pad Warming SystemDWJ · Traditional | Xodus Medical, Inc. | 04/16/2026SE |
| K252861 | Warming SystemDWJ · Traditional | Hangzhou Tappa Medical Technology Co., Ltd. | 04/07/2026SE |
| K251974 | Arctic Sun Temperature Management System (Model 5000)DWJ · Traditional | Medivance, Inc. | 10/24/2025SE |
| K242964 | Celsi WarmerDWJ · Traditional | Hadleigh Health Technologies | 06/20/2025SE |
| K243942 | Arctic Sun Stat Temperature Management SystemDWJ · Traditional | Medivance, Inc. | 04/30/2025SE |
| K232627 | HotDog Warming Mattress + Return ElectrodeDWJ · Special | Augustine Temperature Management, LLC | 04/18/2024SE |
| K232502 | Cocoon Convective Warming System, Model CWS7000DWJ · Traditional | Care Essentials Pty, Ltd. | 02/21/2024SE |
More from Care Essentials Pty, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K920761 | Urine Cultur Stabilization Transport TubeLIO · Traditional | 06/19/1992SE |
| K903410 | Bio-Medicus Cannula IntroducerDYB · Traditional | 10/31/1990SE |
| K901253 | (PBS) Portable Bypass System, Model 1000DTZ · Traditional | 09/05/1990SE |
| K901584 | Bio-Medicus Bio Console Models 540 a B CDWA · Traditional | 06/28/1990SE |
| K884129 | Bio-Medicus Percutaneous Cannula & Introducer SetDQY · Traditional | 12/21/1988SE |
| K883956 | Bio-Medicus Tubing ConnectorsDTL · Traditional | 10/28/1988SE |
| K872033 | Bio-Medicus Cannula-TubingDWF · Traditional | 12/07/1987SE |
| K861096 | Cardiopulmonary Cannula TubingDWF · Traditional | 05/21/1986SE |
| K854133 | Bio Medicus Bio Console 540DWA · Traditional | 01/08/1986SE |
| K853126 | Bio Pack Model 200DWA · Traditional | 10/11/1985SE |
Questions and answers
When was Bio-Cal 370 Heater/Cooler cleared by the FDA?
Bio-Cal 370 Heater/Cooler (K894980) received a 510(k) decision of Substantially Equivalent on November 2, 1989, 86 days after the submission was received.
What is the product code of K894980?
The FDA product code is DWJ – System, Thermal Regulating, a Class II (moderate risk) device regulated under 21 CFR 870.5900.