FDA product code DWJ: System, Thermal Regulating
DWJ is the FDA product code for system, thermal regulating. It is a Class II device, regulated under 21 CFR 870.5900 and reviewed by the Cardiovascular panel. FDA has cleared 161 510(k) submissions under DWJ, 18 in the last five years, from 77 different applicants. The average 510(k) review took 140 days (median 105); 165 days on average over the last three years. FDA has posted 70 recalls for DWJ devices, 19 initiated in the last five years.
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).
Classification
| Field | Value |
|---|---|
| Device name | System, Thermal Regulating |
| Device class | Class II |
| Regulation | 21 CFR 870.5900 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DWJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 5 | 134 |
| 2018 | 3 | 86 |
| 2019 | 2 | 286 |
| 2020 | 5 | 54 |
| 2021 | 2 | 44 |
| 2022 | 2 | 188 |
| 2023 | 6 | 74 |
| 2024 | 2 | 210 |
| 2025 | 3 | 173 |
| 2026 | 5 | 112 |
Compare with all 510(k) review times · Search every DWJ clearance
Top DWJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Augustine Medical, Inc. | 12 | 2002-07-09 |
| Medivance, Inc. | 10 | 2025-10-24 |
| Cincinnati Sub-Zero Products, Inc. | 9 | 2013-01-17 |
| Gaymar Industries, Inc. | 6 | 2011-01-20 |
| Mtre Advanced Technology , Ltd. | 6 | 2010-11-18 |
72 more applicants have DWJ clearances. See the full list in Caduvo.
Most recent DWJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262089 | Hangzhou Tappa Medical Technology Co., Ltd. | Disposable Warming Blanket | 2026-08-21 | 60 |
| K261437 | The Surgical Company International B.V., doing business as TSC Life | Mistral-Air® Warming System | 2026-08-07 | 99 |
| K260278 | Stihler Electronic GmbH | ThermAffyx(TM) Patient Safety System | 2026-07-08 | 160 |
| K260903 | Xodus Medical, Inc. | Hot Pink Pad Warming System | 2026-04-16 | 29 |
| K252861 | Hangzhou Tappa Medical Technology Co., Ltd. | Warming System | 2026-04-07 | 210 |
Recalls for DWJ devices
70 product recalls in 49 recall events; 19 initiated in the last five years and 16 still open. Most recent: 2026-07-13.
| Year | Recalls |
|---|---|
| 2017 | 6 |
| 2018 | 7 |
| 2019 | 5 |
| 2020 | 2 |
| 2021 | 1 |
| 2022 | 5 |
| 2024 | 10 |
| 2025 | 1 |
| 2026 | 3 |
Frequently asked questions
What is FDA product code DWJ?
DWJ is the FDA product code for system, thermal regulating. It is a Class II device, regulated under 21 CFR 870.5900 and reviewed by the Cardiovascular panel.
What device class is DWJ?
Class II, regulation 21 CFR 870.5900. Typical premarket route: 510(k).
How long does a 510(k) take for product code DWJ?
Across 161 cleared submissions the average was 140 days from receipt to decision (median 105).
Which companies have the most DWJ clearances?
Augustine Medical, Inc. (12); Medivance, Inc. (10); Cincinnati Sub-Zero Products, Inc. (9); Gaymar Industries, Inc. (6); Mtre Advanced Technology , Ltd. (6).
Have DWJ devices been recalled?
Yes: 70 product recalls across 49 recall events; the most recent began 2026-07-13.
Next steps
- Run an FDA pathway report with predicate devices for product code DWJ
- Run a recall and safety report across every DWJ manufacturer
- Watch product code DWJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Cardiovascular product codes · FDA product code lookup · 510(k) database search · 510(k) review times