Hypotension Decision Assist (HDA)
Hypotension Decision Assist (HDA) is clinical decision-support software for anesthesia professionals managing blood pressure during surgery. It receives continuous arterial-pressure…
Hypotension Decision Assist (HDA) is clinical decision-support software for anesthesia professionals managing blood pressure during surgery. It receives continuous arterial-pressure waveforms and cardiovascular measurements from a separate multiparameter patient monitor. Its indicated patient group is adults aged eighteen or older whose arterial pressure is continuously monitored.
HDA presents graphs and numerical values, compares mean arterial pressure with clinician-set targets, and indicates when pressure is outside the selected range. Users can mark vasopressor administration and volume challenges on the pressure trend to place those events alongside the measurements.
Listed Item
Hypotension Decision Assist HDA-OR2 is a clinical decision support Software as a Medical Device (SaMD) that is installed upon a medically-rated touch-screen tablet computer. HDA-OR2 connects to a multi-parameter patient monitor supplied by other manufacturers, from which it acquires vital signs data continuously including the arterial blood pressure waveform and cardiovascular-related numeric parameters. HDA-OR2 continually processes this data to display, in graphical charts and numeric format, vital signs data and derived variables including mean arterial pressure (MAP), heart rate, systolic and diastolic blood pressure, cardiac output and systemic vascular resistance. HDA-OR2 compares MAP to user set targets to indicate when MAP is above or below the target range. It allows the user to mark the administration of vasopressors and volume challenges to the MAP trend.
Computer and Signal Processing
The software runs on a medical-grade touch-screen computer connected to the vital-signs monitor. It derives mean arterial pressure, cardiac output, systolic and diastolic pressure, and heart rate from the incoming arterial waveform. The display also includes systemic vascular resistance.
Who Else Makes It
Concentrated in Guangdong (4), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
Record
| Listed by | Directed Systems Ltd, United Kingdom |
|---|---|
| FDA product code | DXG |
| Device type | Computer, Diagnostic, Pre-Programmed, Single-Function |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1435 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K190955 |
| Record published | 2020-06-22 |
| Record revised | 2026-07-21 (version 5) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HDA-OR1 | In distribution | |
| HDA-OR2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| LiDCO Ltd | Lidco Ltd. | 133 |
| LiDCO | Lidco Ltd. | 32 |
| Transonic | Transonic Systems, Inc. | 31 |
| Computer, Diagnostic, Pre-Programmed, Single-Function | Edwards Lifesciences Technology Sarl | 23 |
| Retia Medical | Retia Medical, LLC | 17 |
| EV1000 | Edwards Lifesciences Technology Sarl | 11 |
| Computer, Diagnostic, Pre-Programmed, Single-Function | GE Healthcare Finland OY | 5 |
| Pediasat | Edwards Lifesciences Technology Sarl | 4 |
| LiDCO | Masimo Corporation | 4 |
| ICU Medical | ICU Medical, Inc | 4 |
| Cnap® Monitor 500 HD | Cnsystems Medizintechnik GmbH | 4 |
| Vigileo | Edwards Lifesciences Technology Sarl | 3 |
Showing 12 of 39. All products under Computer, Diagnostic, Pre-Programmed, Single-Function
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K212529 | 2021-11-23 |
| K190955 | 2019-11-27 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.