510(k) · Cleared
ClearedDinamap Pro 1000 Monitor with Superstat, Model 1000
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 May 13, 2003 as substantially equivalent to K012915 (Ge Medical Systems Information Technologies, 2002) after a 260-day review. Its family tree reaches back 2 generations to 2000. 1 of the 27 devices in its family, counting itself, has a Class I recall. 23 later devices descend from it.
- Decided
- May 13, 2003
- Review
- 260 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001359 (2000). 3 ancestors in all. 23 later devices descend from it, 2 citing it directly. 1 of the 27 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK001359 Dash 3000/4000 Patient MonitorGeneral Electric Medical Systems Information Techn · 2000 · Recalled
- 1 generation backK012915 Dinamap Pro 1000 Monitor, Model 1000Ge Medical Systems Information Technologies · 2002 · Recalled
- This deviceK022834 Dinamap Pro 1000 Monitor with Superstat, Model 1000Ge Medical Systems Information Technologies · 2003
- Descendant · cites it directly · 20 of its ownK073203 Carescape V100Ge Medical Systems Information Technologies · 2007
- Descendant · 2 generations on · 11 of its ownK102426 Carescape Model V100 Vital Signs MonitorGe Medical Systems Information Technologies · 2010
- Descendant · 2 generations on · 10 of its ownK120598 Procare Monitor B40Ge Medical Systems China Co., Ltd. · 2012 · Recalled
- Descendant · 3 generations on · 8 of its ownK130584 Monitor B40Ge Medical Systems China Co., Ltd. · 2013 · Recalled
- Descendant · 4 generations on · 7 of its ownK133576 Monitor B40Ge Medical Systems China Co., Ltd. · 2014 · Recalled (Class I)
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K133576 Monitor B404 generations on · 2014
Most influential descendants
Showing 5 of 23 · See all- K073203Carescape V100Ge Medical Systems Information Technologies · 2007 · cites it directly20descendants
- K102426Carescape Model V100 Vital Signs MonitorGe Medical Systems Information Technologies · 2010 · 2 generations on11descendants
- K120598Procare Monitor B40Ge Medical Systems China Co., Ltd. · 2012 · 2 generations on10descendants
- K130584Monitor B40Ge Medical Systems China Co., Ltd. · 2013 · 3 generations on8descendants
- K133576Monitor B40Ge Medical Systems China Co., Ltd. · 2014 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001359 | Dash 3000/4000 Patient Monitor | General Electric Medical Systems Information Techn | 2000 | 1 |
| −1 | K012915 | Dinamap Pro 1000 Monitor, Model 1000 | Ge Medical Systems Information Technologies | 2002 | 1 |
| 0 (this device) | K022834 | Dinamap Pro 1000 Monitor with Superstat, Model 1000 | Ge Medical Systems Information Technologies | 2003 | — |
| +1 | K073203 | Carescape V100 | Ge Medical Systems Information Technologies | 2007 | — |
| +2 | K102426 | Carescape Model V100 Vital Signs Monitor | Ge Medical Systems Information Technologies | 2010 | — |
| +2 | K120598 | Procare Monitor B40 | Ge Medical Systems China Co., Ltd. | 2012 | 2 |
| +3 | K130584 | Monitor B40 | Ge Medical Systems China Co., Ltd. | 2013 | 2 |
| +4 | K133576 | Monitor B40 | Ge Medical Systems China Co., Ltd. | 2014 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 1 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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.
1 device in this family has a Class I recall. 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? (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 |
|---|---|---|---|
| * | K012915 | Dinamap Pro 1000 Monitor, Model 1000 | 2002 |
What descends from it? (23)
See all 232 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K133576Monitor B40Ge Medical Systems China Co., Ltd. · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K073203 (Ge Medical Systems Information Technologies, 2007) has gone furthest, with 20 descendants of its own.
- 1 other device also cites its predicate K012915.
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 DINAMAPB Pro 1000 with SuperStat Monitor is intended to monitor the following adult, pediatric and neonate patient vital signs: Non-Invasive Blood Presure: *Able to measure oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure) *Will optimize performance in the presence of artifact due to vibration and patient motion. ~Non-invasive blood pressure determinations acquired concurrently with the ECG parameter will…
Read the full statement (130 words)
The DINAMAPB Pro 1000 with SuperStat Monitor is intended to monitor the following adult, pediatric and neonate patient vital signs:
Non-Invasive Blood Presure:
*Able to measure oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure)
*Will optimize performance in the presence of artifact due to vibration and patient motion.
~Non-invasive blood pressure determinations acquired concurrently with the ECG parameter will report a determination in the presence of an irregular heart rhythm in the adultlpediatric mode.
Headpulse rate, respiration rate, ECG
Oxygen saturation (SpO2) by noninvasive pulse oximetry and
Predictive temperature by resistive thermometry.
The Pro 1000 with SuperStat Monitor also detects alarm limit conditions and is capable of recording up to two waveforms. Using the monitor a clinician can view, record and recall clinical data derived from each parameter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022834 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022834: Dinamap Pro 1000 Monitor with Superstat, Model 1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022834
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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