510(k) · Cleared
ClearedMRI Patient Monitor TeslaDUO
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mipm Mammendorfer Institut Fur Physik Und Medizin · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Jun 28, 2016 as substantially equivalent to K142032 (Mipm Mammendorfer Institut Fur Physik Und Medizin, 2015) after a 183-day review. Its family tree reaches back 10 generations to 1995.
- Decided
- Jun 28, 2016
- Review
- 183 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K946306 (1995). 36 ancestors in all, the oldest K844187 (1985). No later device cites it as a predicate yet.
- Root · 10 generations backK946306 Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring SystemSiemens Medical Solutions USA, Inc. · 1995
- 6 generations between
- 3 generations backK053484 Infinity Gamma / Gammaxl, Infinity VistaDraeger Medical Systems, Inc. · 2006 · Recalled
- 2 generations backK071802 Tesla Guard, Model Eft G04Mammendorfer Institut Fur Physik Und Medizin GmbH · 2007
- 1 generation backK142032 Mri Patient Monitoring System Tesla M3Mipm Mammendorfer Institut Fur Physik Und Medizin · 2015
- This deviceK153739 MRI Patient Monitor TeslaDUOMipm Mammendorfer Institut Fur Physik Und Medizin · 2016
Show all 10 generations
- Root · 10 generations backK946306 Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring SystemSiemens Medical Solutions USA, Inc. · 1995
- 9 generations backK982730 SC 7000 & SC 9000 XL Infinity Modular Bedside MonitorSiemens Medical Solutions USA, Inc. · 1998
- 8 generations backK983632 Siemens SC 8000 Bedside MonitorSiemens Medical Solutions USA, Inc. · 1998
- 7 generations backK022889 Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC…Siemens Medical Solutions USA, Inc. · 2002
- 6 generations backK031340 Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC…Siemens Medical Solutions USA, Inc. · 2003
- 5 generations backK040188 Infinity Gammaxl and SC 6802XL with the Scio Gas ModuleDraeger Medical Systems, Inc. · 2004
- 4 generations backK042656 Infinity Gamma/Gammaxl and Vista with VF5Draeger Medical Systems, Inc. · 2004
- 3 generations backK053484 Infinity Gamma / Gammaxl, Infinity VistaDraeger Medical Systems, Inc. · 2006 · Recalled
- 2 generations backK071802 Tesla Guard, Model Eft G04Mammendorfer Institut Fur Physik Und Medizin GmbH · 2007
- 1 generation backK142032 Mri Patient Monitoring System Tesla M3Mipm Mammendorfer Institut Fur Physik Und Medizin · 2015
- This deviceK153739 MRI Patient Monitor TeslaDUOMipm Mammendorfer Institut Fur Physik Und Medizin · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K946306 | Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring System | Siemens Medical Solutions USA, Inc. | 1995 | — |
| −9 | K982730 | SC 7000 & SC 9000 XL Infinity Modular Bedside Monitor | Siemens Medical Solutions USA, Inc. | 1998 | — |
| −8 | K983632 | Siemens SC 8000 Bedside Monitor | Siemens Medical Solutions USA, Inc. | 1998 | — |
| −7 | K022889 | Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL &… | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −6 | K031340 | Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with… | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −5 | K040188 | Infinity Gammaxl and SC 6802XL with the Scio Gas Module | Draeger Medical Systems, Inc. | 2004 | — |
| −4 | K042656 | Infinity Gamma/Gammaxl and Vista with VF5 | Draeger Medical Systems, Inc. | 2004 | — |
| −3 | K053484 | Infinity Gamma / Gammaxl, Infinity Vista | Draeger Medical Systems, Inc. | 2006 | 1 |
| −2 | 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 | — |
| 0 (this device) | 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 |
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? (1)
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 |
|---|---|---|---|
| * | K142032 | Mri Patient Monitoring System Tesla M3Summary page 5…II Classification Panel: Cardiovascular Section 5 Page 1 of 5 5. Legally Marketed Predicate Device(s) K142032, MRI Patient Monitoring System Tesla M3 MIPM Mammendorfer Institut für Physik und Medizin GmbH 6. Device Description The… | 2015 |
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 21 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 36 ancestors has a recall of any class.
- 1 other device also cites its predicate K142032.
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. 2016, 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 MRI Patient Monitor TeslaDUO is intended for monitoring of vital signs during MRI examinations (MRI procedures) of patients.
The TeslaDUO is intended for use in the Adult and Pediatric populations for continuous monitoring of Pulse Oximetry (SpO2).
The TeslaDUO is intended for use in the Adult, Pediatric and Neonatal populations for continuous monitoring of Non-Invasive Blood Pressure (NIBP).
The TeslaDUO is intended for use by health care professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153739 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153739: MRI Patient Monitor TeslaDUO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153739
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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