510(k) · Cleared
Cleared3880 MRI Patient Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iradimed Corporation · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Oct 25, 2017 as substantially equivalent to K142032 (Mipm Mammendorfer Institut Fur Physik Und Medizin, 2015) after a 96-day review. Its family tree reaches back 10 generations to 1995. 2 later devices descend from it.
- Decided
- Oct 25, 2017
- Review
- 96 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). 2 later devices descend from it, 2 citing it directly.
- 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 deviceK172200 3880 MRI Patient Monitoring SystemIradimed Corporation · 2017
- Descendant · cites it directly · 0 of its ownK180903 3880 MRI Patient Monitoring SystemIradimed Corporation · 2019
- Descendant · cites it directly · 0 of its ownK182900 3880 MRI Patient Monitoring SystemIradimed Corporation · 2018
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 deviceK172200 3880 MRI Patient Monitoring SystemIradimed Corporation · 2017
Most influential descendants
Showing 2 of 2 · See allView 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) | K172200 | 3880 MRI Patient Monitoring System | Iradimed Corporation | 2017 | — |
| +1 | K180903 | 3880 MRI Patient Monitoring System | Iradimed Corporation | 2019 | — |
| +1 | K182900 | 3880 MRI Patient Monitoring System | Iradimed Corporation | 2018 | — |
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 |
|---|---|---|
| 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? (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 4…Predicate device: Tesla M3 MRI Patient Monitoring System Manufacturer: MIPM (Mammendorfer Institut für Physik und Medizin) 510(k) #: K142032 Clearance date: May 7th, 2015 DEVICE DESCRIPTION: The 3880 MRI Patient Monitoring System, also referred to as the 388… | 2015 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 22 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 36 ancestors has a recall of any class.
- Of its descendants, K180903 (Iradimed Corporation, 2019) has gone furthest, with 0 descendants of its own.
- 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. 2017, 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 IRadimed Corporation’s 3880 MRI Patient Monitoring System is intended to monitor a single patient’s vital signs for patients undergoing Magnetic Resonance Imaging (MRI) procedures. The 3880 MRI Patient Monitoring System is intended for use by healthcare professionals. The 3880 MRI Patient Monitoring System is intended for use in Adult and Pediatric, including Neonatal populations, for monitoring of Electrocardiogram (ECG), Non-Invasive Blood Pressure…
Read the full statement (176 words)
The IRadimed Corporation’s 3880 MRI Patient Monitoring System is intended to monitor a single patient’s vital signs for patients undergoing Magnetic Resonance Imaging (MRI) procedures.
The 3880 MRI Patient Monitoring System is intended for use by healthcare professionals.
The 3880 MRI Patient Monitoring System is intended for use in Adult and Pediatric, including Neonatal populations, for monitoring of Electrocardiogram (ECG), Non-Invasive Blood Pressure (NIBP), and Temperature.
The 3880 MRI Patient Monitoring System is also intended for use in Adult and Pediatric, not including Neonatal populations, for monitoring of Pulse Oximetry (SpO2), Anesthetic Agents, Respiration, Capnography (C0O2), and Oxygen (02).
The 3880 MRI Patient Monitoring System provides monitoring for three distinct patient types as defined below (Note:
Pediatric group excludes Neonates):
Patient Type Age
1 Adult greater than 22 years
2 Pediatric (Includes: Infant, Child and Adolescent)
-Adolescent aged 12 through 21 (up to but not including the 22nd birthday)
-Child 2 years to less than 12 years
-Infant 29 days to less than 2 years
3 Neonate from birth through the first 28 days of life
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K172200 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172200: 3880 MRI Patient Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172200
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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