510(k) · Cleared
Recalled · Class II · 2026Vital Signs Monitor W/Arrhythmia Detection and ST Analysis, Model 8100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Criticare Systems, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Apr 17, 2003 as substantially equivalent to K012059 (Criticare Systems, Inc., 2001) after a 50-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it. It has been recalled once.
- Decided
- Apr 17, 2003
- Review
- 50 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K942737 (1995). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK942737 Poet IQ with Five Agent CapabilityCriticare Systems, Inc. · 1995
- 1 generation backK012059 8100/8500 Vital Signs MonitorCriticare Systems, Inc. · 2001
- This deviceK030613 Vital Signs Monitor W/Arrhythmia Detection and ST Analysis, Model 8100Criticare Systems, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK101602 Vital Signs MonitorCriticare Systems, Inc. · 2010
Most influential descendants
Showing 1 of 1 · See all- K101602Vital Signs MonitorCriticare Systems, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K942737 | Poet IQ with Five Agent Capability | Criticare Systems, Inc. | 1995 | — |
| −1 | K012059 | 8100/8500 Vital Signs Monitor | Criticare Systems, Inc. | 2001 | — |
| 0 (this device) | K030613 | Vital Signs Monitor W/Arrhythmia Detection and ST Analysis, Model 8100 | Criticare Systems, Inc. | 2003 | — |
| +1 | K101602 | Vital Signs Monitor | Criticare Systems, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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? (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.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101602 | Vital Signs Monitor | 2010 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 6, 2026 | Class II | Z-3253-2026 | Process design | Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure delay. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 1 company; a new generation was cleared every 6.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K101602 (Criticare Systems, Inc., 2010) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K012059.
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?
This system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional health care provider. Physiological data, system alarms and patient data analysis will be available to the care provider from the monitor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030613 · printed Nov 4, 2026
Cite this page
510(k) Report. “K030613: Vital Signs Monitor W/Arrhythmia Detection and ST Analysis, Model 8100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030613
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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