Mini-Temp(Tm)
FDA 510(k) K881322 · Seabrook Medical Systems, Inc.
510(k) numberK881322
Submission
- Device name
- Mini-Temp(Tm)
- Applicant
- Seabrook Medical Systems, Inc.
Cincinnati, OH, US - Received
- March 28, 1988
- Decision date
- June 22, 1988
- 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 |
|---|---|---|
| K952086 | Tropicair Convective Warming BlanketsDWJ · Traditional | 09/06/1995SE |
| K946196 | Tropicair Convective Waring SystemDWJ · Traditional | 09/06/1995SE |
| K931203 | Cool-AidILO · Traditional | 02/22/1994SE |
| K923104 | Tropic-AirDWJ · Traditional | 07/13/1993SE |
| K914182 | Golden Thermal(R)ILO · Traditional | 10/18/1991SE |
| K902756 | Tropi-CoolDWJ · Traditional | 10/22/1990SE |
| K902269 | Electri-Cool(Tm) Liquid-Circulat. Thermal TherapyILO · Traditional | 06/21/1990SE |
| K902268 | Pedia-Temp(Tm) Liquid-Circulating Hypo-Hypertherm.ILO · Traditional | 06/21/1990SE |
| K882310 | Dual-Temp(Tm) Cooling/Warming UnitILO · Traditional | 09/23/1988SE |
| K873699 | Ecmo-Temp (TM) Blood Warming DeviceDWC · Traditional | 12/22/1987SE |
Questions and answers
When was Mini-Temp(Tm) cleared by the FDA?
Mini-Temp(Tm) (K881322) received a 510(k) decision of Substantially Equivalent on June 22, 1988, 86 days after the submission was received.
What is the product code of K881322?
The FDA product code is DWJ – System, Thermal Regulating, a Class II (moderate risk) device regulated under 21 CFR 870.5900.