DWJClass II
System, Thermal Regulating
21 CFR 870.5900 / Cardiovascular
DWJ is the FDA product code for System, Thermal Regulating, a class II device type, regulated under 21 CFR 870.5900. FDA's definition for this code reads: "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)". As of , FDA records hold 161 510(k) clearances under this code, the most recent dated , and 70 recalls.
Classification record
- Product code
- DWJ
- Device name
- System, Thermal Regulating
- FDA definition
- 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).
- Regulation
- 21 CFR 870.5900
- Device class
- Class II
- Review panel
- Cardiovascular
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 161
- Ingested recalls
- 70
Clearances, product code DWJ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1977 | 3 |
| 1980 | 1 |
| 1981 | 4 |
| 1982 | 1 |
| 1986 | 1 |
| 1987 | 1 |
| 1988 | 4 |
| 1989 | 2 |
| 1990 | 4 |
| 1991 | 5 |
| 1992 | 7 |
| 1993 | 3 |
| 1994 | 2 |
| 1995 | 7 |
| 1996 | 2 |
| 1997 | 5 |
| 1998 | 1 |
| 2000 | 7 |
| 2001 | 3 |
| 2002 | 6 |
| 2003 | 3 |
| 2004 | 5 |
| 2006 | 10 |
| 2007 | 4 |
| 2008 | 3 |
| 2009 | 3 |
| 2010 | 8 |
| 2011 | 4 |
| 2012 | 5 |
| 2013 | 5 |
| 2014 | 4 |
| 2016 | 2 |
| 2017 | 5 |
| 2018 | 3 |
| 2019 | 2 |
| 2020 | 5 |
| 2021 | 2 |
| 2022 | 2 |
| 2023 | 6 |
| 2024 | 2 |
| 2025 | 3 |
| 2026 | 5 |
Applicants with the most clearances
Product code DWJ| Applicant | Clearances |
|---|---|
| Augustine Medical, Inc. | 12 |
| Medivance Inc. | 10 |
| Gentherm Medical, LLC | 9 |
| Gaymar Industries, Inc. | 6 |
| Mtre Advanced Technology, Ltd. | 6 |
| Iob Medical, Inc. | 5 |
| Seabrook Medical Systems, Inc. | 5 |
| Augustine Biomedical & Design, LLC | 4 |
| Augustine Temperature Management, LLC | 4 |
| Medtronic, Inc. | 4 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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