Gibeck Warmbag Reusable Convective Warming Blanket
FDA 510(k) K960511 · Gibeck, Inc.
510(k) numberK960511
Submission
- Device name
- Gibeck Warmbag Reusable Convective Warming Blanket
- Applicant
- Gibeck, Inc.
Indianapolis, IN, US - Received
- February 5, 1996
- Decision date
- January 13, 1997
- 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 |
|---|---|---|
| K965016 | Iso-Gard Filter ANGLED(18212)/ISO-GARD Filter STRAIGHT(19212)CAH · Traditional | 12/02/1997SE |
| K964377 | Thermal Regulation System BlanketDWJ · Traditional | 04/23/1997SE |
| K964382 | Humid-Vent Filter Compact Angled (18402)/HUMID-VENT Filter Compact STRAIGHT(19402)CAH · Traditional | 04/15/1997SE |
| K954828 | Iso-Gard Hepa Filter-Hme, Iso-Ard Hepa Filter-Hme W/PortCAH · Traditional | 05/02/1996SE |
| K953544 | Humid-Vent 2 Light/Humid-Vent 2 Port LightBYD · Traditional | 08/25/1995SE |
| K953491 | Humid-Vent 1 Port/Humid-Vent 1 Port AngleBYD · Traditional | 08/25/1995SE |
| K952845 | Humid-Vent Trach-VentBYD · Traditional | 07/25/1995SE |
| K952844 | Humid-Vent 2BYD · Traditional | 07/20/1995SE |
| K952750 | Humid-Vent 1BYD · Traditional | 07/20/1995SE |
| K952084 | Humid-Vent Filter PediBYD · Traditional | 06/12/1995SE |
Questions and answers
When was Gibeck Warmbag Reusable Convective Warming Blanket cleared by the FDA?
Gibeck Warmbag Reusable Convective Warming Blanket (K960511) received a 510(k) decision of Substantially Equivalent on January 13, 1997, 343 days after the submission was received.
What is the product code of K960511?
The FDA product code is DWJ – System, Thermal Regulating, a Class II (moderate risk) device regulated under 21 CFR 870.5900.