PDTClass II
Burn Resuscitation Decision Support Software
21 CFR 868.1890 / Anesthesiology
PDT is the FDA product code for Burn Resuscitation Decision Support Software, a class II device type, regulated under 21 CFR 868.1890. FDA's definition for this code reads: "The burn resuscitation decision support system (BRDSS) is intended for use in prediction of hourly fluid volume during initial 24 hours of burn resuscitation. It is intended for patients who have greater than 20% total body surface area burn". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- PDT
- Device name
- Burn Resuscitation Decision Support Software
- FDA definition
- The burn resuscitation decision support system (BRDSS) is intended for use in prediction of hourly fluid volume during initial 24 hours of burn resuscitation. It is intended for patients who have greater than 20% total body surface area burn.
- Regulation
- 21 CFR 868.1890
- Device class
- Class II
- Review panel
- Anesthesiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 2
- Ingested recalls
- 1
Clearances, product code PDT
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2013 | 1 |
| 2014 | 1 |
Applicants with the most clearances
Product code PDT| Applicant | Clearances |
|---|---|
| Arcos, Inc. | 1 |
| The Surgeon General, Department of the Army | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code PDT.
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