510(k) · Cleared
Recalled · Class II · 2018Patient Monitor, Models Dash 3000, 4000 and 5000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Information Technologies · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Jun 20, 2005 as substantially equivalent to K033304 (Ge Medical Systems Information Technologies, 2003) and 3 other predicates after a 26-day review. Its family tree reaches back 6 generations to 1996. 9 later devices descend from it. It has been recalled once.
- Decided
- Jun 20, 2005
- Review
- 26 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 6 generations to K963644 (1996). 24 ancestors in all, the oldest K904039 (1990). 9 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK963644 A-1000 Eeg Monitor and a-1050 Eeg MonitorAspect Medical Systems, Inc. · 1996
- 5 generations backK974496 A-2000 Eeg Monitor with BisAspect Medical Systems, Inc. · 1998
- 4 generations backK012466 Bis/Eeg ModuleGeneral Electric Medical Systems Information Techn · 2001
- 3 generations backK031694 Modification to Eeg Monitor with Bis, Model a-2000Aspect Medical Systems, Inc. · 2003
- 2 generations backK030267 Eeg Monitor with Bis, Model a-2000Aspect Medical Systems, Inc. · 2004
- 1 generation backK040183 BISXAspect Medical Systems, Inc. · 2004
- This deviceK051367 Patient Monitor, Models Dash 3000, 4000 and 5000Ge Medical Systems Information Technologies · 2005
- Descendant · cites it directly · 8 of its ownK073462 Modification to Dash 3000, 4000, 5000 Monitor and AccessoriesGe Medical Systems Information Technologies · 2008 · Recalled
- Descendant · 2 generations on · 6 of its ownK080461 Star ST and Arrhythmia Software, Release J.0Philips Medical Systems · 2008
- Descendant · 3 generations on · 4 of its ownK101521 ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems · 2010
- Descendant · 4 generations on · 1 of its ownK150352 V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015
- Descendant · 3 generations on · 0 of its ownK152305 Nihon Kohden Afib Detection Program QP-039PNihon Kohden Corporation · 2016
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K073462Modification to Dash 3000, 4000, 5000 Monitor and AccessoriesGe Medical Systems Information Technologies · 2008 · cites it directly8descendants
- K080461Star ST and Arrhythmia Software, Release J.0Philips Medical Systems · 2008 · 2 generations on6descendants
- K101521ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems · 2010 · 3 generations on4descendants
- K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · 4 generations on1descendant
- K152305Nihon Kohden Afib Detection Program QP-039PNihon Kohden Corporation · 2016 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K963644 | A-1000 Eeg Monitor and a-1050 Eeg Monitor | Aspect Medical Systems, Inc. | 1996 | — |
| −5 | K974496 | A-2000 Eeg Monitor with Bis | Aspect Medical Systems, Inc. | 1998 | — |
| −4 | K012466 | Bis/Eeg Module | General Electric Medical Systems Information Techn | 2001 | — |
| −3 | K031694 | Modification to Eeg Monitor with Bis, Model a-2000 | Aspect Medical Systems, Inc. | 2003 | — |
| −2 | K030267 | Eeg Monitor with Bis, Model a-2000 | Aspect Medical Systems, Inc. | 2004 | — |
| −1 | K040183 | BISX | Aspect Medical Systems, Inc. | 2004 | — |
| 0 (this device) | K051367 | Patient Monitor, Models Dash 3000, 4000 and 5000 | Ge Medical Systems Information Technologies | 2005 | — |
| +1 | K073462 | Modification to Dash 3000, 4000, 5000 Monitor and Accessories | Ge Medical Systems Information Technologies | 2008 | 9 |
| +2 | K080461 | Star ST and Arrhythmia Software, Release J.0 | Philips Medical Systems | 2008 | — |
| +3 | K101521 | ST/AR ST and Arrhythmia Software Model: Release K.O | Philips Medical Systems | 2010 | — |
| +4 | K150352 | V Series Monitoring System (including V12 and V21 Monitors) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | — |
| +3 | K152305 | Nihon Kohden Afib Detection Program QP-039P | Nihon Kohden Corporation | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 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? (4)
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 |
|---|---|---|---|
| * | K033304 | Modification to Dash 3000/4000 Patient MonitorSummary page 1…etection Or Alarms) MH-X 21 CFR 870.2770 Plethysmograph, Impedance OS B Preicat Device K<033304 DASH 3000/4000 Patient Monitor K<012891 Nellcor Puritan Bennett N-595 Pulse Oximeter… | 2003 |
| * | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables…Summary page 1…mpedance OS B Preicat Device K<033304 DASH 3000/4000 Patient Monitor K<012891 Nellcor Puritan Bennett N-595 Pulse Oximeter 1<983684 Datex Ohmeda SpO2… | 2002 |
| * | K983684 | Datex-Ohmeda 3800+/3800P+ or 3900/3900P Pulse OximetersSummary page 1…at Device K<033304 DASH 3000/4000 Patient Monitor K<012891 Nellcor Puritan Bennett N-595 Pulse Oximeter 1<983684 Datex Ohmeda SpO2 K<040183 Aspect Medical Device Descritionn The DASH 3000/4000/50… | 1998 |
| * | K040183 | BISXSummary page 1…K<012891 Nellcor Puritan Bennett N-595 Pulse Oximeter 1<983684 Datex Ohmeda SpO2 K<040183 Aspect Medical Device Descritionn The DASH 3000/4000/5000 Patient Monitor is a device that isdesigned… | 2004 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073462 | Modification to Dash 3000, 4000, 5000 Monitor and Accessories | 2008 | 8 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 31, 2018 | Class II | Z-0521-2019 | Software design | The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 7 of the 24 ancestors have a recall of any class.
- Of its descendants, K073462 (Ge Medical Systems Information Technologies, 2008) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K033304.
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 DASH 3000/4000/5000 Patient Monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The DASH 3000/4000/5000 is designed as a bedside, portable, and transport monitor that can operate in all professional medical facilities and medical transport modes including but not limited to: emergency…
Read the full statement (222 words)
The DASH 3000/4000/5000 Patient Monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The DASH 3000/4000/5000 is designed as a bedside, portable, and transport monitor that can operate in all professional medical facilities and medical transport modes including but not limited to: emergency department, operating room, post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, freestanding surgical centers, and other alternate care facilities, intra-hospital patient transport, inter-hospital patient transport via ground vehicles (i.e, ambulance, etc.) and fixed and rotary winged aircraft, and pre-hospital emergency response.
Physiologic data includes but is not restricted to: electrocardiogram, invasive blood pressure, noninvasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, carbon dioxide, oxygen, and anesthetic agents as summarized in the operators manual.
The DASH 3000/4000/5000 Patient Monitor is also intended to provide physiologic data over the Unity network to clinical information systems and allow the user to access hospital data at the point-of-care.
This information can be displayed, trended, stored, and printed.
The DASH 3000/4000/5000 Patient Monitor was developed to interface with non-proprietary third party peripheral devices that support serial data outputs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051367 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051367: Patient Monitor, Models Dash 3000, 4000 and 5000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051367
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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