510(k) · Cleared
ClearedNavigator Clinical Guidence System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Physiology Pty, Ltd. · DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Cleared on May 12, 2010 as substantially equivalent to K072735 (Pulsion Medical Systems AG, 2007) after a 294-day review. Its family tree reaches back 1 generation to 2007. 2 later devices descend from it.
- Decided
- May 12, 2010
- Review
- 294 days
- Class
- Class II
- Product code
- DXG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K072735 (2007). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK072735 Pulsion Picco-2, Model 8500Pulsion Medical Systems AG · 2007
- This deviceK092219 Navigator Clinical Guidence SystemApplied Physiology Pty, Ltd. · 2010
- Descendant · cites it directly · 1 of its ownK190955 Hypotension Decision AssistDirected Systems, Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK212529 Hypotension Decision Assist Model HDA-OR2Directed Systems, Ltd. · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K072735 | Pulsion Picco-2, Model 8500 | Pulsion Medical Systems AG | 2007 | — |
| 0 (this device) | K092219 | Navigator Clinical Guidence System | Applied Physiology Pty, Ltd. | 2010 | — |
| +1 | K190955 | Hypotension Decision Assist | Directed Systems, Ltd. | 2019 | — |
| +2 | K212529 | Hypotension Decision Assist Model HDA-OR2 | Directed Systems, Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K072735 | Pulsion Picco-2, Model 8500Summary page 1…d diagnostic computer 510(k) Classification Class 11 2 iCER 870.1435 Predicate Devices The Navigator is substantially equivalent to the following predicate device(s): *K072 735 PI'VUlsw/ PICCO 2 *K023 ,966I. i19COphIis HemodynarniicMonitor Device Description The Naviga~tor is a physiologically integrat… | 2007 |
| Kept off the family tree | K023966 | FDA’s K023966 is Disposable BI-Polar Cable Our reading of the summary gave K023966, FDA’s number for Disposable BI-Polar Cable (Modern Medical Equipment Mfg., Ltd.). Its FDA name has none of the distinctive words the summary uses for the device it names, “PiCCOplus Hemodynamic Monitor”. Kept off the family tree. | 2003 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190955 | Hypotension Decision Assist | 2019 | 1 |
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?
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. 2010, 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?
The Navigator-TM is indicated for the acquisition, processing, and display of hemodynamic parameters, in order to assist the clinician in achieving and maintaining a prescribed target hemodynamic stability.
Mean Systemic Filling Pressure (Pms) and Heart Efficiency (Eh) parameters are calculated by the Navigator from Cardiac Output (CO), Mean Arterial Pressure (MAP) and Right Atrial Pressure (RAP) data, obtained directly from patient monitoring equipment, and other data obtained by manual clinician entry. The Navigator system provides a visual indication of the patient's circulatory status in relation to predetermined goals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092219 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092219: Navigator Clinical Guidence System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092219
Report an extraction error
Are you the manufacturer?
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