510(k) · Cleared
ClearedHypotension Decision Assist Model HDA-OR2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Directed Systems, Ltd. · DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Cleared on Nov 23, 2021 as substantially equivalent to K190955 (Directed Systems, Ltd., 2019) after a 104-day review. Its family tree reaches back 3 generations to 2007.
- Decided
- Nov 23, 2021
- Review
- 104 days
- Class
- Class II
- Product code
- DXG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K072735 (2007). No later device cites it as a predicate yet.
- Root · 3 generations backK072735 Pulsion Picco-2, Model 8500Pulsion Medical Systems AG · 2007
- 2 generations backK092219 Navigator Clinical Guidence SystemApplied Physiology Pty, Ltd. · 2010
- 1 generation backK190955 Hypotension Decision AssistDirected Systems, Ltd. · 2019
- This deviceK212529 Hypotension Decision Assist Model HDA-OR2Directed Systems, Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K072735 | Pulsion Picco-2, Model 8500 | Pulsion Medical Systems AG | 2007 | — |
| −2 | K092219 | Navigator Clinical Guidence System | Applied Physiology Pty, Ltd. | 2010 | — |
| −1 | K190955 | Hypotension Decision Assist | Directed Systems, Ltd. | 2019 | — |
| 0 (this device) | K212529 | Hypotension Decision Assist Model HDA-OR2 | Directed Systems, Ltd. | 2021 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DXG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DXG device
- #1 K253092 Argos Infinity (Rev. 1.0)score 11.1 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K190955 | Hypotension Decision AssistSummary page 4…ssification Name: Single-function, preprogrammed diagnostic computer Regulation: 21 CFR 870.1435 Product Code: DXG Predicate Device: Hypotension Decision Assist HDA-OR1 (K190955) 002_Updated Summary Page 1 of 4 K212529 Directed Syste… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All DXG devicesDXG Computer, Diagnostic, Pre-Programmed, Single-Function: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · DXG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXG
290in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXG
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXG
8in 2025
MAUDE reports naming product code DXG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 43 |
| 2008 | 5 | 118 | 1 | 37 |
| 2009 | 0 | — | 6 | 8 |
| 2010 | 4 | 282 | 1 | 17 |
| 2011 | 3 | 104 | 0 | 7 |
| 2012 | 2 | — | 0 | 29 |
| 2013 | 3 | 236 | 0 | 23 |
| 2014 | 6 | 290 | 0 | 44 |
| 2015 | 1 | — | 0 | 34 |
| 2016 | 1 | — | 0 | 67 |
| 2017 | 1 | — | 0 | 62 |
| 2018 | 2 | — | 0 | 83 |
| 2019 | 2 | — | 0 | 81 |
| 2020 | 1 | — | 2 | 49 |
| 2021 | 1 | — | 0 | 29 |
| 2022 | 0 | — | 0 | 44 |
| 2023 | 1 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 21 |
| 2025 | 1 | — | 0 | 8 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Hypotension Decision Assist is indicated to acquire, process and display arterial pressure and other key cardiovascular
characteristics of adult patients who are at least eighteen years of age that are undergoing surgery where their arterial
pressure is being continuously monitored by a vital-signs monitor. It is indicated for use to assist anesthesia healthcare
professionals manage the blood pressure, hemodynamic stability and the cardiovascular system during such surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212529 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212529: Hypotension Decision Assist Model HDA-OR2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212529
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026