510(k) · Cleared
ClearedTeslaguard, Model Eft G04
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mammendorfer Institute For Physics & Medicine GmbH · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Jan 3, 2006 as substantially equivalent to K033600 (Draeger Medical Systems, Inc., 2003) and 3 other predicates after a 152-day review. Its family tree reaches back 5 generations to 1985. 6 later devices descend from it.
- Decided
- Jan 3, 2006
- Review
- 152 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K844187 (1985). 13 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK844187 Siemens Sirecust 404N Neonatal MonitorSiemens Medical Solutions USA, Inc. · 1985
- 4 generations backK952054 Siemens Sirecust Monitoring (1200, 1200 Neo, 960)Siemens Medical Solutions USA, Inc. · 1996
- 3 generations backK962404 Siemens SC 6000 & SC 6000 P Portable Bedside Monitoring SystemSiemens Medical Solutions USA, Inc. · 1997
- 2 generations backK993974 Siemens Infinity SC 6002XL Portable Patient MonitorSiemens Medical Solutions USA, Inc. · 2000
- 1 generation backK033600 Infinity GammaxlDraeger Medical Systems, Inc. · 2003
- This deviceK052119 Teslaguard, Model Eft G04Mammendorfer Institute For Physics & Medicine GmbH · 2006
- Descendant · cites it directly · 5 of its ownK071802 Tesla Guard, Model Eft G04Mammendorfer Institut Fur Physik Und Medizin GmbH · 2007
- Descendant · 2 generations on · 4 of its ownK142032 Mri Patient Monitoring System Tesla M3Mipm Mammendorfer Institut Fur Physik Und Medizin · 2015
- Descendant · 3 generations on · 2 of its ownK172200 3880 MRI Patient Monitoring SystemIradimed Corporation · 2017
- Descendant · 4 generations on · 0 of its ownK180903 3880 MRI Patient Monitoring SystemIradimed Corporation · 2019
- Descendant · 4 generations on · 0 of its ownK182900 3880 MRI Patient Monitoring SystemIradimed Corporation · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K071802Tesla Guard, Model Eft G04Mammendorfer Institut Fur Physik Und Medizin GmbH · 2007 · cites it directly5descendants
- K142032Mri Patient Monitoring System Tesla M3Mipm Mammendorfer Institut Fur Physik Und Medizin · 2015 · 2 generations on4descendants
- K1722003880 MRI Patient Monitoring SystemIradimed Corporation · 2017 · 3 generations on2descendants
- K1809033880 MRI Patient Monitoring SystemIradimed Corporation · 2019 · 4 generations on0descendants
- K1829003880 MRI Patient Monitoring SystemIradimed Corporation · 2018 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K844187 | Siemens Sirecust 404N Neonatal Monitor | Siemens Medical Solutions USA, Inc. | 1985 | — |
| −4 | K952054 | Siemens Sirecust Monitoring (1200, 1200 Neo, 960) | Siemens Medical Solutions USA, Inc. | 1996 | — |
| −3 | K962404 | Siemens SC 6000 & SC 6000 P Portable Bedside Monitoring System | Siemens Medical Solutions USA, Inc. | 1997 | — |
| −2 | K993974 | Siemens Infinity SC 6002XL Portable Patient Monitor | Siemens Medical Solutions USA, Inc. | 2000 | — |
| −1 | K033600 | Infinity Gammaxl | Draeger Medical Systems, Inc. | 2003 | — |
| 0 (this device) | K052119 | Teslaguard, Model Eft G04 | Mammendorfer Institute For Physics & Medicine GmbH | 2006 | — |
| +1 | K071802 | Tesla Guard, Model Eft G04 | Mammendorfer Institut Fur Physik Und Medizin GmbH | 2007 | — |
| +2 | K142032 | Mri Patient Monitoring System Tesla M3 | Mipm Mammendorfer Institut Fur Physik Und Medizin | 2015 | — |
| +3 | K172200 | 3880 MRI Patient Monitoring System | Iradimed Corporation | 2017 | — |
| +4 | K180903 | 3880 MRI Patient Monitoring System | Iradimed Corporation | 2019 | — |
| +4 | K182900 | 3880 MRI Patient Monitoring System | Iradimed Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 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? (5)
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 |
|---|---|---|---|
| * | K033600 | Infinity GammaxlSummary page 2…Date: Page 2 of 2 Predicate Devices Infinity Gamma XL manufactured by Driger Medical Systems Inc. (K033600, K030313, K017016, K990563, K983632) Safety & Effectiveness Safety Testing The Tesla Guard complies with the Safety Testing requ… | 2003 |
| * | K030313 | Siemens Infinity SC 6002XL ModificationsSummary page 2…te: Page 2 of 2 Predicate Devices Infinity Gamma XL manufactured by Driger Medical Systems Inc. (K033600, K030313, K017016, K990563, K983632) Safety & Effectiveness Safety Testing The Tesla Guard complies with the Safety Testing requirements… | 2003 |
| Kept off the family tree | K017016 | Infinity Gamma XL Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2…Page 2 of 2 Predicate Devices Infinity Gamma XL manufactured by Driger Medical Systems Inc. (K033600, K030313, K017016, K990563, K983632) Safety & Effectiveness Safety Testing The Tesla Guard complies with the Safety Testing requirements of EN 606… | |
| * | K990563 | Siemens SC 8000 Bedside Monitor with Advanced Communication OptionSummary page 2…Page 2 of 2 Predicate Devices Infinity Gamma XL manufactured by Driger Medical Systems Inc. (K033600, K030313, K017016, K990563, K983632) Safety & Effectiveness Safety Testing The Tesla Guard complies with the Safety Testing requirements of EN 6060 1-1 (IE… | 1999 |
| * | K983632 | Siemens SC 8000 Bedside MonitorSummary page 2…Page 2 of 2 Predicate Devices Infinity Gamma XL manufactured by Driger Medical Systems Inc. (K033600, K030313, K017016, K990563, K983632) Safety & Effectiveness Safety Testing The Tesla Guard complies with the Safety Testing requirements of EN 6060 1-1 (IEC 60 1-1)… | 1998 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071802 | Tesla Guard, Model Eft G04 | 2007 | 5 |
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 21 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K071802 (Mammendorfer Institut Fur Physik Und Medizin GmbH, 2007) has gone furthest, with 5 descendants of its own.
- 4 other devices also cite its predicate K033600.
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.
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) This device will produce visual and audible alarms if any of these parameters vary beyond preset limits. 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…
Read the full statement (128 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)
This device will produce visual and audible alarms if any of these parameters vary beyond preset limits.
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/K052119 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052119: Teslaguard, 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/K052119
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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