Bair Hugger Model 600 Unit, Blankets
FDA 510(k) K950416 · Augustine Medical, Inc.
510(k) numberK950416
Submission
- Device name
- Bair Hugger Model 600 Unit, Blankets
- Applicant
- Augustine Medical, Inc.
Eden Prairie, MN, US - Received
- January 31, 1995
- Decision date
- August 29, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K021473 | Bair Hugger Temperature Management SystemDWJ · Traditional | 07/09/2002SE |
| K020077 | Modification to Augustine Medical Wound Care System, Model 68XXXMSA · Special | 01/31/2002SE |
| K001149 | Augustine Medical Bair Huuger, Model 750 Total Temperature Management System-(Model 750…DWJ · Traditional | 09/06/2000SE |
| K973741 | Bair Hugger Blood/Fluid WarmerBSB · Traditional | 04/30/1998SE |
| K964673 | Bair Hugger Model 630 Cardiac BlanketDWJ · Traditional | 06/26/1997SE |
| K963293 | Augustine Medical Wound Care System Model 68XXXMSA · Traditional | 03/28/1997SN |
| K963672 | Model 90022 Rolling StandJOW · Traditional | 01/06/1997SE |
| K960167 | System, Thermal Regulating 74-DWJDWJ · Traditional | 06/17/1996SE |
| K954446 | Augustine Intubation GuideCCW · Traditional | 12/29/1995SE |
| K952864 | Bair Hugger Model 655 BlanketDWJ · Traditional | 09/12/1995SE |
Questions and answers
When was Bair Hugger Model 600 Unit, Blankets cleared by the FDA?
Bair Hugger Model 600 Unit, Blankets (K950416) received a 510(k) decision of Substantially Equivalent on August 29, 1995, 210 days after the submission was received.
What is the product code of K950416?
The FDA product code is DWJ – System, Thermal Regulating, a Class II (moderate risk) device regulated under 21 CFR 870.5900.