510(k) · Cleared
ClearedHypotension Decision Assist
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 27, 2019 as substantially equivalent to K092219 (Applied Physiology Pty, Ltd., 2010) after a 230-day review. Its family tree reaches back 2 generations to 2007. 1 later device descends from it.
- Decided
- Nov 27, 2019
- Review
- 230 days
- Class
- Class II
- Product code
- DXG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K072735 (2007). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK072735 Pulsion Picco-2, Model 8500Pulsion Medical Systems AG · 2007
- 1 generation backK092219 Navigator Clinical Guidence SystemApplied Physiology Pty, Ltd. · 2010
- This deviceK190955 Hypotension Decision AssistDirected Systems, Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK212529 Hypotension Decision Assist Model HDA-OR2Directed Systems, Ltd. · 2021
Most influential descendants
Showing 1 of 1 · See all- K212529Hypotension Decision Assist Model HDA-OR2Directed Systems, Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K072735 | Pulsion Picco-2, Model 8500 | Pulsion Medical Systems AG | 2007 | — |
| −1 | K092219 | Navigator Clinical Guidence System | Applied Physiology Pty, Ltd. | 2010 | — |
| 0 (this device) | K190955 | Hypotension Decision Assist | Directed Systems, Ltd. | 2019 | — |
| +1 | K212529 | Hypotension Decision Assist Model HDA-OR2 | Directed Systems, Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
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 11.2 · 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 |
|---|---|---|---|
| * | K092219 | Navigator Clinical Guidence SystemSummary page 4…sion support software Classification Name: Single-function, preprogrammed diagnostic computer Regulation: 21 CFR 870.1435 Product Code: DXG Predicate Device: Navigator™ (K092219) from Applied Physiology Pty Ltd Reference Devices: CardioQ-EDM+ (K172457) from Deltex Medical Ltd IntelliVue Patient Monitor MX5… | 2010 |
| † | K172457 | Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM | 2018 |
| † | K161531 | IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2… | 2016 |
| † | K132533 | Carescape Monitor B450 | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212529 | Hypotension Decision Assist Model HDA-OR2 | 2021 | 0 |
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 12 years and passes through 3 companies; a new generation was cleared every 9.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K212529 (Directed Systems, Ltd., 2021) has gone furthest, with 0 descendants of its own.
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. 2019, 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/K190955 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190955: Hypotension Decision Assist.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190955
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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