510(k) · Cleared
ClearedSmartpilot View Model MK04500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Draeger Medical GmbH · BSZ Gas-Machine, Anesthesia
Cleared on Mar 28, 2012 as substantially equivalent to K071097 (GE Healthcare Finland Oy, 2007) and 7 other predicates after a 532-day review. Its family tree reaches back 10 generations to 2000.
- Decided
- Mar 28, 2012
- Review
- 532 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 10 generations to K000647 (2000). 33 ancestors in all, the oldest K900598 (1990). No later device cites it as a predicate yet.
- Root · 10 generations backK000647 Datex-Ohmeda Network and CentralDatex-Ohmeda, Inc. · 2000
- 6 generations between
- 3 generations backK081941 Navigator Applications SuiteGE Healthcare Finland Oy · 2008
- 2 generations backK083098 Navigator Applications SuiteGE Healthcare Finland Oy · 2009
- 1 generation backK102389 Navigator Applications SuiteGE Healthcare Finland Oy · 2011
- This deviceK103035 Smartpilot View Model MK04500Draeger Medical GmbH · 2012
Show all 10 generations
- Root · 10 generations backK000647 Datex-Ohmeda Network and CentralDatex-Ohmeda, Inc. · 2000
- 9 generations backK013246 Datex-Ohmeda S/5 Network and Central '01Datex-Ohmeda · 2001
- 8 generations backK022507 Datex-Ohmeda S/5 Network and Central '02Datex-Ohmeda · 2002
- 7 generations backK033281 Datex Ohmeda S/5 Network and Central (Icentral) '03 with L-NET03…Datex-Ohmeda · 2003
- 6 generations backK042771 GE Datex-Ohmeda S/5 Network and Icentral '03, Sales Revision 3.3Datex-Ohmeda · 2004
- 5 generations backK052972 Datex-Ohmeda Network and Icentral '05, Sales Revision 4.3GE Healthcare · 2005 · Recalled
- 4 generations backK071097 Navigator Applications SuiteGE Healthcare Finland Oy · 2007
- 3 generations backK081941 Navigator Applications SuiteGE Healthcare Finland Oy · 2008
- 2 generations backK083098 Navigator Applications SuiteGE Healthcare Finland Oy · 2009
- 1 generation backK102389 Navigator Applications SuiteGE Healthcare Finland Oy · 2011
- This deviceK103035 Smartpilot View Model MK04500Draeger Medical GmbH · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K000647 | Datex-Ohmeda Network and Central | Datex-Ohmeda, Inc. | 2000 | — |
| −9 | K013246 | Datex-Ohmeda S/5 Network and Central '01 | Datex-Ohmeda | 2001 | — |
| −8 | K022507 | Datex-Ohmeda S/5 Network and Central '02 | Datex-Ohmeda | 2002 | — |
| −7 | K033281 | Datex Ohmeda S/5 Network and Central (Icentral) '03 with L-NET03 Software | Datex-Ohmeda | 2003 | — |
| −6 | K042771 | GE Datex-Ohmeda S/5 Network and Icentral '03, Sales Revision 3.3 | Datex-Ohmeda | 2004 | — |
| −5 | K052972 | Datex-Ohmeda Network and Icentral '05, Sales Revision 4.3 | GE Healthcare | 2005 | 3 |
| −4 | K071097 | Navigator Applications Suite | GE Healthcare Finland Oy | 2007 | — |
| −3 | K081941 | Navigator Applications Suite | GE Healthcare Finland Oy | 2008 | — |
| −2 | K083098 | Navigator Applications Suite | GE Healthcare Finland Oy | 2009 | — |
| −1 | K102389 | Navigator Applications Suite | GE Healthcare Finland Oy | 2011 | — |
| 0 (this device) | K103035 | Smartpilot View Model MK04500 | Draeger Medical GmbH | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 3 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 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? (9)
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 |
|---|---|---|---|
| * | K071097 | Navigator Applications SuiteSummary page 3…cate): With respect to the pharmacokinetic and pharmacodynamic calculation and display of data the Smart Pilot View is equivalent to the Navigator Applications Suite (K<071097, K<081941, K<083098, 1102389) from GE Healthcare Finland Qy. The display of the monitoring data is equivalent to the Software Inf… | 2007 |
| * | K081941 | Navigator Applications SuiteSummary page 3…th respect to the pharmacokinetic and pharmacodynamic calculation and display of data the Smart Pilot View is equivalent to the Navigator Applications Suite (K<071097, K<081941, K<083098, 1102389) from GE Healthcare Finland Qy. The display of the monitoring data is equivalent to the Software Infinity Expl… | 2008 |
| * | K083098 | Navigator Applications SuiteSummary page 3…to the pharmacokinetic and pharmacodynamic calculation and display of data the Smart Pilot View is equivalent to the Navigator Applications Suite (K<071097, K<081941, K<083098, 1102389) from GE Healthcare Finland Qy. The display of the monitoring data is equivalent to the Software Infinity Explorer (K103… | 2009 |
| * | K102389 | Navigator Applications Suite Cleared while this submission was under review Summary page 3…harmacokinetic and pharmacodynamic calculation and display of data the Smart Pilot View is equivalent to the Navigator Applications Suite (K<071097, K<081941, K<083098, 1102389) from GE Healthcare Finland Qy. The display of the monitoring data is equivalent to the Software Infinity Explorer (K103515, K022… | 2011 |
| Kept off the family tree | K103515 | FDA’s K103515 is Equal Dose Our reading of the summary gave K103515, FDA’s number for Equal Dose (Nucletron Corporation). Its FDA name has none of the distinctive words the summary uses for the device it names, “Software Infinity Explorer”. Kept off the family tree. Summary page 3…ications Suite (K<071097, K<081941, K<083098, 1102389) from GE Healthcare Finland Qy. The display of the monitoring data is equivalent to the Software Infinity Explorer (K103515, K022889,1K030615, K040945, K<060254) from Draeger Medical Systems, Inc.. March 2012… | 2011 |
| * | K022889 | Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL & Siemens…Summary page 3…Suite (K<071097, K<081941, K<083098, 1102389) from GE Healthcare Finland Qy. The display of the monitoring data is equivalent to the Software Infinity Explorer (K103515, K022889,1K030615, K040945, K<060254) from Draeger Medical Systems, Inc.. March 2012… | 2002 |
| * | K030615 | Infinity ExplorerSummary page 3…071097, K<081941, K<083098, 1102389) from GE Healthcare Finland Qy. The display of the monitoring data is equivalent to the Software Infinity Explorer (K103515, K022889,1K030615, K040945, K<060254) from Draeger Medical Systems, Inc.. March 2012… | 2003 |
| * | K040945 | Modification to Infinity ExplorerSummary page 3…<081941, K<083098, 1102389) from GE Healthcare Finland Qy. The display of the monitoring data is equivalent to the Software Infinity Explorer (K103515, K022889,1K030615, K040945, K<060254) from Draeger Medical Systems, Inc.. March 2012… | 2004 |
| * | K060254 | Modification to Infinity ExplorerSummary page 3…083098, 1102389) from GE Healthcare Finland Qy. The display of the monitoring data is equivalent to the Software Infinity Explorer (K103515, K022889,1K030615, K040945, K<060254) from Draeger Medical Systems, Inc.. March 2012 Page 3… | 2006 |
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 12 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 33 ancestors has a recall of any class.
- 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. 2012, 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?
The SmartPilot View is software which monitors and logs the dosage of intravenous and volatile drugs administered to a human being. Additionally, SmartPilot View displays pharmacokinetic, pharmacodynamic (PKIPD) and interactive P'D modeling information. Smart Pilot provides the health care professional with theoretical information about the modeled effect of supported anesthesia pharmaceuticals delivered to the patient. The SmartPilot View is software…
Read the full statement (122 words)
The SmartPilot View is software which monitors and logs the dosage of intravenous and volatile drugs administered to a human being. Additionally, SmartPilot View displays pharmacokinetic, pharmacodynamic (PKIPD) and interactive P'D modeling information.
Smart Pilot provides the health care professional with theoretical information about the modeled effect of supported anesthesia pharmaceuticals delivered to the patient.
The SmartPilot View is software for use by health care professionals trained in the application of general anaesthesia.
The SmartPilot View is intended for use with data, from adults only. The demographic ranges for these patient data are as follows:
Height 59 in to 79 in (150 cm to 200 cm)
Weight 88 lb to 309 lb (40 kg to 140 kg)
Age 18 to 90 years
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103035 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103035: Smartpilot View Model MK04500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103035
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