510(k) · Cleared
ClearedTesla Guard, Model Eft G04
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mammendorfer Institut Fur Physik Und Medizin GmbH · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Nov 9, 2007 as substantially equivalent to K052119 (Mammendorfer Institute For Physics & Medicine GmbH, 2006) and 1 other predicate after a 130-day review. Its family tree reaches back 8 generations to 1995. 5 later devices descend from it.
- Decided
- Nov 9, 2007
- Review
- 130 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K946306 (1995). 34 ancestors in all, the oldest K844187 (1985). 5 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK946306 Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring SystemSiemens Medical Solutions USA, Inc. · 1995
- 7 generations backK982730 SC 7000 & SC 9000 XL Infinity Modular Bedside MonitorSiemens Medical Solutions USA, Inc. · 1998
- 6 generations backK983632 Siemens SC 8000 Bedside MonitorSiemens Medical Solutions USA, Inc. · 1998
- 5 generations backK022889 Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC…Siemens Medical Solutions USA, Inc. · 2002
- 4 generations backK031340 Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC…Siemens Medical Solutions USA, Inc. · 2003
- 3 generations backK040188 Infinity Gammaxl and SC 6802XL with the Scio Gas ModuleDraeger Medical Systems, Inc. · 2004
- 2 generations backK042656 Infinity Gamma/Gammaxl and Vista with VF5Draeger Medical Systems, Inc. · 2004
- 1 generation backK053484 Infinity Gamma / Gammaxl, Infinity VistaDraeger Medical Systems, Inc. · 2006 · Recalled
- This deviceK071802 Tesla Guard, Model Eft G04Mammendorfer Institut Fur Physik Und Medizin GmbH · 2007
- Descendant · cites it directly · 4 of its ownK142032 Mri Patient Monitoring System Tesla M3Mipm Mammendorfer Institut Fur Physik Und Medizin · 2015
- Descendant · 2 generations on · 2 of its ownK172200 3880 MRI Patient Monitoring SystemIradimed Corporation · 2017
- Descendant · 3 generations on · 0 of its ownK180903 3880 MRI Patient Monitoring SystemIradimed Corporation · 2019
- Descendant · 3 generations on · 0 of its ownK182900 3880 MRI Patient Monitoring SystemIradimed Corporation · 2018
- Descendant · 2 generations on · 0 of its ownK153739 MRI Patient Monitor TeslaDUOMipm Mammendorfer Institut Fur Physik Und Medizin · 2016
Most influential descendants
Showing 5 of 5 · See all- K142032Mri Patient Monitoring System Tesla M3Mipm Mammendorfer Institut Fur Physik Und Medizin · 2015 · cites it directly4descendants
- K1722003880 MRI Patient Monitoring SystemIradimed Corporation · 2017 · 2 generations on2descendants
- K1809033880 MRI Patient Monitoring SystemIradimed Corporation · 2019 · 3 generations on0descendants
- K1829003880 MRI Patient Monitoring SystemIradimed Corporation · 2018 · 3 generations on0descendants
- K153739MRI Patient Monitor TeslaDUOMipm Mammendorfer Institut Fur Physik Und Medizin · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K946306 | Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring System | Siemens Medical Solutions USA, Inc. | 1995 | — |
| −7 | K982730 | SC 7000 & SC 9000 XL Infinity Modular Bedside Monitor | Siemens Medical Solutions USA, Inc. | 1998 | — |
| −6 | K983632 | Siemens SC 8000 Bedside Monitor | Siemens Medical Solutions USA, Inc. | 1998 | — |
| −5 | K022889 | Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL &… | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −4 | K031340 | Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with… | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −3 | K040188 | Infinity Gammaxl and SC 6802XL with the Scio Gas Module | Draeger Medical Systems, Inc. | 2004 | — |
| −2 | K042656 | Infinity Gamma/Gammaxl and Vista with VF5 | Draeger Medical Systems, Inc. | 2004 | — |
| −1 | K053484 | Infinity Gamma / Gammaxl, Infinity Vista | Draeger Medical Systems, Inc. | 2006 | 1 |
| 0 (this device) | K071802 | Tesla Guard, Model Eft G04 | Mammendorfer Institut Fur Physik Und Medizin GmbH | 2007 | — |
| +1 | K142032 | Mri Patient Monitoring System Tesla M3 | Mipm Mammendorfer Institut Fur Physik Und Medizin | 2015 | — |
| +2 | K172200 | 3880 MRI Patient Monitoring System | Iradimed Corporation | 2017 | — |
| +3 | K180903 | 3880 MRI Patient Monitoring System | Iradimed Corporation | 2019 | — |
| +3 | K182900 | 3880 MRI Patient Monitoring System | Iradimed Corporation | 2018 | — |
| +2 | K153739 | MRI Patient Monitor TeslaDUO | Mipm Mammendorfer Institut Fur Physik Und Medizin | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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 MWI? 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 MWI device
- #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K052119 | Teslaguard, Model Eft G04Summary page 2…information to the TeslaGuard Patient Monitor. The other intended uses of the TeslaGuard remain unchanged. Predicate Devices MIPM TeslaGuard® as cleared under 510(k) # K052119 Draeger Infinity Gamma XL as cleared under 5 10(k) # K053484 Non Clinical Testing Laboratory bench testing was conducted to vali… | 2006 |
| * | K053484 | Infinity Gamma / Gammaxl, Infinity VistaSummary page 2…ended uses of the TeslaGuard remain unchanged. Predicate Devices MIPM TeslaGuard® as cleared under 510(k) # K052119 Draeger Infinity Gamma XL as cleared under 5 10(k) # K053484 Non Clinical Testing Laboratory bench testing was conducted to validate performance specifications of the multi-gas module. Simu… | 2006 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142032 | Mri Patient Monitoring System Tesla M3 | 2015 | 4 |
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 1.4 years on median.
- 1 of the 34 ancestors has a recall of any class.
- Of its descendants, K142032 (Mipm Mammendorfer Institut Fur Physik Und Medizin, 2015) has gone furthest, with 4 descendants of its own.
How does its category compare?
All MWI devicesMWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · MWI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWI
247in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWI
9so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWI
182in 2025
MAUDE reports naming product code MWI, 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 | 9 | 42 | 1 | 3 |
| 2008 | 9 | 49 | 1 | 3 |
| 2009 | 6 | 112 | 2 | 20 |
| 2010 | 17 | 58 | 2 | 17 |
| 2011 | 11 | 78 | 3 | 16 |
| 2012 | 13 | 104 | 5 | 31 |
| 2013 | 20 | 85 | 3 | 42 |
| 2014 | 16 | 148 | 6 | 30 |
| 2015 | 19 | 127 | 1 | 31 |
| 2016 | 12 | 165 | 0 | 51 |
| 2017 | 13 | 205 | 2 | 85 |
| 2018 | 11 | 217 | 0 | 158 |
| 2019 | 14 | 255 | 4 | 169 |
| 2020 | 8 | 138 | 0 | 110 |
| 2021 | 9 | 161 | 0 | 188 |
| 2022 | 5 | 231 | 2 | 168 |
| 2023 | 8 | 250 | 0 | 179 |
| 2024 | 10 | 202 | 5 | 120 |
| 2025 | 4 | 247 | 0 | 182 |
| 2026 | 6 | 239 | 9 | — |
What is it indicated for?
The TeslaGuard® Patient Monitor is capable of monitoring: SpO2 (Arterial Oxygen Saturation) ECG (3-Lead) IBP (Invasive Blood Pressure) NIBP (Non-invasive Blood Pressure) CO2 and Anesthetic Agents (with optional multi-gas module) This device will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings. With the optional multi-gas module installed, sampled breathing gases from adults and…
Read the full statement (193 words)
The TeslaGuard® Patient Monitor is capable of monitoring:
SpO2 (Arterial Oxygen Saturation)
ECG (3-Lead)
IBP (Invasive Blood Pressure)
NIBP (Non-invasive Blood Pressure)
CO2 and Anesthetic Agents (with optional multi-gas module)
This device will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings.
With the optional multi-gas module installed, sampled breathing gases from adults and pediatrics can be displayed. The multi-gas module continuously measures the content of CO2, N2O, O2 and one of the anesthetic agents, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane in any mixture, and communicates real time and derived gas information to the TeslaGuard® Patient Monitor.
The device is intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the use of the device, who will determine when use of the device is indicated based upon their professional assessment of the patient's medical condition,
The device is intended for use in the Adult, Pediatric and Neonatal populations.
MRI Compatibility Statement
The TeslaGuard Patient Monitor is designed for use in an MRI-environment at a maximum magnetic field strength of 20mT.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071802 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071802: Tesla Guard, Model Eft G04.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071802
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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