510(k) · Cleared
ClearedNavigator Applications Suite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare Finland Oy · BSZ Gas-Machine, Anesthesia
Cleared on Jun 10, 2011 as substantially equivalent to K071097 (GE Healthcare Finland Oy, 2007) and 2 other predicates after a 291-day review. Its family tree reaches back 9 generations to 2000. 1 later device descends from it.
- Decided
- Jun 10, 2011
- Review
- 291 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K000647 (2000). 12 ancestors in all, the oldest K000815 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK000647 Datex-Ohmeda Network and CentralDatex-Ohmeda, Inc. · 2000
- 5 generations between
- 3 generations backK071097 Navigator Applications SuiteGE Healthcare Finland Oy · 2007
- 2 generations backK081941 Navigator Applications SuiteGE Healthcare Finland Oy · 2008
- 1 generation backK083098 Navigator Applications SuiteGE Healthcare Finland Oy · 2009
- This deviceK102389 Navigator Applications SuiteGE Healthcare Finland Oy · 2011
- Descendant · cites it directly · 0 of its ownK103035 Smartpilot View Model MK04500Draeger Medical GmbH · 2012
Show all 9 generations
- Root · 9 generations backK000647 Datex-Ohmeda Network and CentralDatex-Ohmeda, Inc. · 2000
- 8 generations backK013246 Datex-Ohmeda S/5 Network and Central '01Datex-Ohmeda · 2001
- 7 generations backK022507 Datex-Ohmeda S/5 Network and Central '02Datex-Ohmeda · 2002
- 6 generations backK033281 Datex Ohmeda S/5 Network and Central (Icentral) '03 with L-NET03…Datex-Ohmeda · 2003
- 5 generations backK042771 GE Datex-Ohmeda S/5 Network and Icentral '03, Sales Revision 3.3Datex-Ohmeda · 2004
- 4 generations backK052972 Datex-Ohmeda Network and Icentral '05, Sales Revision 4.3GE Healthcare · 2005 · Recalled
- 3 generations backK071097 Navigator Applications SuiteGE Healthcare Finland Oy · 2007
- 2 generations backK081941 Navigator Applications SuiteGE Healthcare Finland Oy · 2008
- 1 generation backK083098 Navigator Applications SuiteGE Healthcare Finland Oy · 2009
- This deviceK102389 Navigator Applications SuiteGE Healthcare Finland Oy · 2011
Most influential descendants
Showing 1 of 1 · See all- K103035Smartpilot View Model MK04500Draeger Medical GmbH · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K000647 | Datex-Ohmeda Network and Central | Datex-Ohmeda, Inc. | 2000 | — |
| −8 | K013246 | Datex-Ohmeda S/5 Network and Central '01 | Datex-Ohmeda | 2001 | — |
| −7 | K022507 | Datex-Ohmeda S/5 Network and Central '02 | Datex-Ohmeda | 2002 | — |
| −6 | K033281 | Datex Ohmeda S/5 Network and Central (Icentral) '03 with L-NET03 Software | Datex-Ohmeda | 2003 | — |
| −5 | K042771 | GE Datex-Ohmeda S/5 Network and Icentral '03, Sales Revision 3.3 | Datex-Ohmeda | 2004 | — |
| −4 | K052972 | Datex-Ohmeda Network and Icentral '05, Sales Revision 4.3 | GE Healthcare | 2005 | 3 |
| −3 | K071097 | Navigator Applications Suite | GE Healthcare Finland Oy | 2007 | — |
| −2 | K081941 | Navigator Applications Suite | GE Healthcare Finland Oy | 2008 | — |
| −1 | K083098 | Navigator Applications Suite | GE Healthcare Finland Oy | 2009 | — |
| 0 (this device) | K102389 | Navigator Applications Suite | GE Healthcare Finland Oy | 2011 | — |
| +1 | K103035 | Smartpilot View Model MK04500 | Draeger Medical GmbH | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 BSZ? 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 BSZ device
- #1 K253330 A5 Anesthesia System (A5); A7 Anesthesia…score 16.7 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K071097 | Navigator Applications SuiteSummary page 1…807.92(a)(3) The Navigator Applications Suite is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Navigator Applications Suite (K071097, K081941, K083098). DEVICE DESCRIPTION as required by 807.92(a)(4) The Navigator Applications Suite isa software product that… | 2007 |
| * | K081941 | Navigator Applications SuiteSummary page 1…)(3) The Navigator Applications Suite is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Navigator Applications Suite (K071097, K081941, K083098). DEVICE DESCRIPTION as required by 807.92(a)(4) The Navigator Applications Suite isa software product that runs on… | 2008 |
| * | K083098 | Navigator Applications SuiteSummary page 1…Navigator Applications Suite is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Navigator Applications Suite (K071097, K081941, K083098). DEVICE DESCRIPTION as required by 807.92(a)(4) The Navigator Applications Suite isa software product that runs on a medical… | 2009 |
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 |
|---|---|---|---|
| K103035 | Smartpilot View Model MK04500 | 2012 | 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 11 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K103035 (Draeger Medical GmbH, 2012) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K071097.
How does its category compare?
All BSZ devicesBSZ Gas-Machine, Anesthesia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · BSZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BSZ
145in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BSZ
5in 2025
Class I (38 since 2007) Class II/III not classified
Adverse event reports per year · BSZ
9,198in 2025
MAUDE reports naming product code BSZ, 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 | 3 | 175 | 1 | 132 |
| 2008 | 8 | 99 | 8 | 104 |
| 2009 | 3 | 34 | 3 | 85 |
| 2010 | 1 | — | 14 | 97 |
| 2011 | 6 | 218 | 1 | 87 |
| 2012 | 5 | 134 | 7 (6) | 89 |
| 2013 | 5 | 125 | 5 (5) | 308 |
| 2014 | 4 | 235 | 0 | 279 |
| 2015 | 4 | 134 | 7 (2) | 572 |
| 2016 | 1 | — | 1 | 2,135 |
| 2017 | 3 | 145 | 5 (1) | 2,355 |
| 2018 | 2 | — | 3 | 2,589 |
| 2019 | 0 | — | 5 (2) | 1,957 |
| 2020 | 1 | — | 7 | 2,687 |
| 2021 | 1 | — | 2 (1) | 3,123 |
| 2022 | 0 | — | 4 (3) | 4,352 |
| 2023 | 2 | — | 6 | 5,595 |
| 2024 | 0 | — | 13 (13) | 6,067 |
| 2025 | 1 | — | 5 (3) | 9,198 |
| 2026 | 2 | — | 7 (2) | — |
What is it indicated for?
Navigator Applications Suite (Navigator) is a software package that includes Navigator Therapy, Navigator Protocol and Navigator Device. Navigator software is loaded into a medical-grade PC mounted on or near the anesthesia delivery system and receives data from supported anesthesia delivery systems, anesthesia patient monitors, intravenous drug infusion pumps and/or electronic record keeping systems. Navigator Therapy displays pharmacokinetic…
Read the full statement (247 words)
Navigator Applications Suite (Navigator) is a software package that includes Navigator Therapy, Navigator Protocol and Navigator Device. Navigator software is loaded into a medical-grade PC mounted on or near the anesthesia delivery system and receives data from supported anesthesia delivery systems, anesthesia patient monitors, intravenous drug infusion pumps and/or electronic record keeping systems.
Navigator Therapy displays pharmacokinetic, pharmacodynamic (PKIPD) and interactive PD modeling information. Navigator Therapy provides the heath care professional with theoretical information about the modeled effect of supported anesthesia pharmaceuticals delivered to the patient.
The theoretical models are for the following patient populations:
Age 18 - 90 years old
Weight 40 - 140 kg / 88.2 to 308.6 pounds
Height 150 - 190 cm / 59.1 to 74.8 inches
Calculated drug concentrations and effects are based on published models, and do not represent actual measurements from a patient. Drug models are calculated and displayed assuming a healthy patient. Navigator is not intended to be the sole source for patient specific guidance on clinical decisions, including dosing decisions for anesthetic drugs. Always refer to the appropriate drug labeling for dosing information and guidance.
Navigator Protocol allows hospitals to load electronic versions of care protocols. This feature can be configured with selected patient monitoring parameters available for viewing in conjunction with the care protocol.
Navigator Device is a troubleshooting aid providing access to certain anesthesia delivery system alarm information.
The system is designed for hospital use and should only be used under the orders of a clinician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102389 · printed Nov 5, 2026
Cite this page
510(k) Report. “K102389: Navigator Applications Suite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102389
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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