510(k) · Cleared
Recalled · 2011Polaris 95000-a Bedside/Transport Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datex-Ohmeda, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Dec 4, 2003 as substantially equivalent to K013046 (Spacelabs Medical, Inc., 2002) and 1 other predicate after a 240-day review. Its family tree reaches back 1 generation to 1994. It has been recalled 2 times.
- Decided
- Dec 4, 2003
- Review
- 240 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 1 generation to K941165 (1994). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK941165 Comet Capnograph ModuleSpacelabs, Inc. · 1994
- This deviceK031124 Polaris 95000-a Bedside/Transport MonitorDatex-Ohmeda, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K941165 | Comet Capnograph Module | Spacelabs, Inc. | 1994 | — |
| 0 (this device) | K031124 | Polaris 95000-a Bedside/Transport Monitor | Datex-Ohmeda, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 MHX? 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 MHX device
- #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 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 |
|---|---|---|---|
| * | K013046 | Cosmos SystemSummary page 1…Classification: Class III Classification Classification Panel: Cardiovascular Devices P Spacelabs 95000 Bedside/Transport Monitor, K013046 (cleared 08/02) Predicate · Spacelabs Comet Capnograph Module (90516), K941165 (cleared 10/94) Devices *… | 2002 |
| * | K941165 | Comet Capnograph ModuleSummary page 1…ardiovascular Devices P Spacelabs 95000 Bedside/Transport Monitor, K013046 (cleared 08/02) Predicate · Spacelabs Comet Capnograph Module (90516), K941165 (cleared 10/94) Devices * Novametrix CO 2SMO Plus Monitor (8100), K963380 (cleared 01/97) Performance FDA… | 1994 |
| † | K963380 | CO 2 Smo Plus | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 12, 2011 | Not classified | Z-2573-2011 | Software design | Capnography Module, Model 91517, resets 20 seconds after power failure, instead of after three minutes as specified. This reset clears the RAM and the module returns to default settings. |
| Jul 20, 2005 | Not classified | Z-0517-06 | Other | The transducer used to compensate for pressure changes was mounted backwards on the printed circuit board assembly. The module will not compensate for pressure changes and CO2 readings will be inaccurate at higher altitudes. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K013046.
How does its category compare?
All MHX devicesMHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MHX
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MHX
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MHX
21so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHX
3,761in 2025
MAUDE reports naming product code MHX, 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 | 15 | 96 | 3 | 131 |
| 2008 | 16 | 58 | 2 | 232 |
| 2009 | 13 | 57 | 7 | 382 |
| 2010 | 20 | 90 | 13 | 955 |
| 2011 | 12 | 81 | 16 | 949 |
| 2012 | 16 | 88 | 11 | 676 |
| 2013 | 21 | 120 | 14 | 1,997 |
| 2014 | 13 | 248 | 6 | 1,609 |
| 2015 | 14 | 203 | 5 | 1,284 |
| 2016 | 13 | 149 | 7 | 1,105 |
| 2017 | 14 | 134 | 6 | 1,115 |
| 2018 | 11 | 203 | 12 | 2,157 |
| 2019 | 7 | 243 | 6 | 1,462 |
| 2020 | 11 | 196 | 0 | 1,714 |
| 2021 | 5 | 195 | 0 | 2,423 |
| 2022 | 15 | 189 | 6 | 1,470 |
| 2023 | 8 | 229 | 3 | 2,254 |
| 2024 | 5 | 181 | 3 | 2,814 |
| 2025 | 8 | 192 | 15 | 3,761 |
| 2026 | 14 | 205 | 21 | — |
What is it indicated for?
The Model 95000-A Bedside/Transport Monitor is used at the patient's bedside to actively acquire, analyze, monitor and display a variety of clinical parameters (in clinically relevant formats) for adults, pediatric or neonatal patients. The Model 95000-A Bedside/Transport Monitor is designed for use by a healthcare professional in a hospital, healthcare facility (ie, clinic), or intra-hospital transport. This product is not designed for home use or for…
Read the full statement (249 words)
The Model 95000-A Bedside/Transport Monitor is used at the patient's bedside to actively acquire, analyze, monitor and display a variety of clinical parameters (in clinically relevant formats) for adults, pediatric or neonatal patients.
The Model 95000-A Bedside/Transport Monitor is designed for use by a healthcare professional in a hospital, healthcare facility (ie, clinic), or intra-hospital transport. This product is not designed for home use or for use in transport vehicles.
The Model 95000-A Bedside/Transport Monitor supports product configurations with almost any combination of clinical parameters that provide the following:
* A means for continuous monitoring of:
* Electrocardiographic signals in order to detect:
* Normal cardiac rhythms, including life-threatening events such as high and low heart rates, asystole and ventricular fibrillation.
* (Adult patients only) Additional abnormal cardiac rhythms, such as ventricular runs and tachycardia, and ST segment deviations.
* Respiratory effort in order to detect abnormal respiration events such as high and low respiration rates and episodes or apnea.
* Invasive blood pressure in order to detect abnormal events such as high and low blood pressure.
* Pulse oxygen saturation in order to detect desaturation due to abnormal pulmonary or circulatory functions.
* Temperature in order to detect abnormal events such as high and low temperatures.
- Carbon dioxide.
* Oxygen.
· A means for episodic monitoring of:
* Non-invasive blood pressure signals to detect abnormal events such as high and low blood pressure.
* (Adult patients only) Various hemodynamic values to detect abnormal cardiac flow (CO) values.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031124 · printed Nov 4, 2026
Cite this page
510(k) Report. “K031124: Polaris 95000-a Bedside/Transport Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K031124
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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