FDA product code PDT: Burn Resuscitation Decision Support Software
PDT is the FDA product code for burn resuscitation decision support software. It is a Class II device, regulated under 21 CFR 868.1890 and reviewed by the General and Plastic Surgery panel. FDA has cleared 2 510(k) submissions under PDT, from 2 different applicants. The average 510(k) review took 314 days (median 314). FDA has posted 1 recall for PDT devices.
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.
Classification
| Field | Value |
|---|---|
| Device name | Burn Resuscitation Decision Support Software |
| Device class | Class II |
| Regulation | 21 CFR 868.1890 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every PDT clearance
Top PDT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| The Surgeon General, Department of the Army | 1 | 2014-12-23 |
| Arcos, Inc. | 1 | 2013-04-18 |
Most recent PDT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K140387 | The Surgeon General, Department of the Army | Burn Resuscitation Decision Support System - Clinical (BRDSS-C) | 2014-12-23 | 312 |
| K121659 | Arcos, Inc. | BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS) | 2013-04-18 | 317 |
Recalls for PDT devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-03-16.
Frequently asked questions
What is FDA product code PDT?
PDT is the FDA product code for burn resuscitation decision support software. It is a Class II device, regulated under 21 CFR 868.1890 and reviewed by the General and Plastic Surgery panel.
What device class is PDT?
Class II, regulation 21 CFR 868.1890. Typical premarket route: 510(k).
How long does a 510(k) take for product code PDT?
Across 2 cleared submissions the average was 314 days from receipt to decision (median 314).
Which companies have the most PDT clearances?
The Surgeon General, Department of the Army (1); Arcos, Inc. (1).
Have PDT devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2015-03-16.
Next steps
- Run an FDA pathway report with predicate devices for product code PDT
- Run a recall and safety report across every PDT manufacturer
- Watch product code PDT 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.
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