Soft-Temp
FDA 510(k) K921920 · Adroit Medical Systems, Inc.
510(k) numberK921920
Submission
- Device name
- Soft-Temp
- Applicant
- Adroit Medical Systems, Inc.
Morganton, NC, US - Received
- April 23, 1992
- Decision date
- December 11, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K073712 | Soft Air, Model SA 4000 and Mistral Air, Model MA0100DWJ · Traditional | 06/06/2008SE |
| K973981 | Safepass Sterilization PouchKCT · Traditional | 01/29/1998SE |
| K970197 | HTP-1500 Localized Heat Therapy PumpILO · Traditional | 09/10/1997SE |
| K962983 | Sterile Soft-TempILO · Traditional | 01/10/1997SE |
| K921928 | Soft-CoverFMW · Traditional | 11/06/1992SE |
Questions and answers
When was Soft-Temp cleared by the FDA?
Soft-Temp (K921920) received a 510(k) decision of Substantially Equivalent on December 11, 1992, 232 days after the submission was received.
What is the product code of K921920?
The FDA product code is DWJ – System, Thermal Regulating, a Class II (moderate risk) device regulated under 21 CFR 870.5900.