Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart B — Diagnostic Devices](/submissions/AN/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 868.1890](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1890) → PDT — Burn Resuscitation Decision Support Software

# PDT · Burn Resuscitation Decision Support Software

_Anesthesiology · 21 CFR 868.1890 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/PDT

## Overview

- **Product Code:** PDT
- **Device Name:** Burn Resuscitation Decision Support Software
- **Regulation:** [21 CFR 868.1890](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1890)
- **Device Class:** 2
- **Review Panel:** [Anesthesiology](/submissions/AN)
- **3rd-party reviewable:** yes

## Identification

A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K140387](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/PDT/K140387.md) | Burn Resuscitation Decision Support System - Clinical (BRDSS-C) | The Surgeon General, Department of the Army | Dec 23, 2014 | SESE |
| [K121659](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/PDT/K121659.md) | BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS) | Arcos, Inc. | Apr 18, 2013 | SESE |

## Top Applicants

- The Surgeon General, Department of the Army — 1 clearance
- Arcos, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/PDT](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/PDT)

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