510(k) · Cleared
ClearedPhilips Drug Calculator Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Nov 29, 2002 as substantially equivalent to K922058 (Hewlett-Packard Co., 1992) and 2 other predicates after a 28-day review. Its family tree reaches back 5 generations to 1994. 17 later devices descend from it.
- Decided
- Nov 29, 2002
- Review
- 28 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K941811 (1994). 21 ancestors in all, the oldest K822695 (1982). 17 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 4 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 3 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 2 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 1 generation backK992636 HP Carevue 9000 Clinical Information System, Model M2331AHewlett-Packard Co. · 1999 · Recalled
- This deviceK023674 Philips Drug Calculator SoftwarePhilips Medical Systems · 2002
- Descendant · cites it directly · 16 of its ownK061110 Glucommander PlusCollaborativemed, LLC · 2006
- Descendant · 2 generations on · 13 of its ownK101344 G+ SystemGlytec, LLC (Formally Known AS Glucotec, Inc.) · 2010
- Descendant · 3 generations on · 12 of its ownK113853 G+ SystemGlytec, LLC · 2012
- Descendant · 4 generations on · 8 of its ownK132547 Endo Tool Glucose Management System (Egms)Monarch Medical Technologies · 2014 · Recalled
- Descendant · 5 generations on · 3 of its ownK200443 EndoTool IV 1.10Monarch Medical Technologies, LLC · 2020
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K061110Glucommander PlusCollaborativemed, LLC · 2006 · cites it directly16descendants
- K101344G+ SystemGlytec, LLC (Formally Known AS Glucotec, Inc.) · 2010 · 2 generations on13descendants
- K113853G+ SystemGlytec, LLC · 2012 · 3 generations on12descendants
- K132547Endo Tool Glucose Management System (Egms)Monarch Medical Technologies · 2014 · 4 generations on8descendants
- K200443EndoTool IV 1.10Monarch Medical Technologies, LLC · 2020 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −4 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −3 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −2 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −1 | K992636 | HP Carevue 9000 Clinical Information System, Model M2331A | Hewlett-Packard Co. | 1999 | 8 |
| 0 (this device) | K023674 | Philips Drug Calculator Software | Philips Medical Systems | 2002 | — |
| +1 | K061110 | Glucommander Plus | Collaborativemed, LLC | 2006 | — |
| +2 | K101344 | G+ System | Glytec, LLC (Formally Known AS Glucotec, Inc.) | 2010 | — |
| +3 | K113853 | G+ System | Glytec, LLC | 2012 | — |
| +4 | K132547 | Endo Tool Glucose Management System (Egms) | Monarch Medical Technologies | 2014 | 1 |
| +5 | K200443 | EndoTool IV 1.10 | Monarch Medical Technologies, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K922058 | Models M1175A and M1176A Component Monitoring SystSummary page 1…Dose Surgery 3. The new device is substantially equivalent to previously cleared Philips devices marketed pursuant to K922058, K992636, and KO21422 4. The modification is primarily a software based change that incorporates the Rule of Six algorithm… | 1992 |
| * | K992636 | HP Carevue 9000 Clinical Information System, Model M2331ASummary page 1…Dose Surgery 3. The new device is substantially equivalent to previously cleared Philips devices marketed pursuant to K922058, K992636, and KO21422 4. The modification is primarily a software based change that incorporates the Rule of Six algorithm for IV d… | 1999 |
| * | K021422 | Philips Information Center Software Revision D.02 | 2002 |
What descends from it? (17)
See all 171 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061110 | Glucommander Plus | 2006 | 16 |
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 8 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 2 of the 21 ancestors have a recall of any class.
- Of its descendants, K061110 (Collaborativemed, LLC, 2006) has gone furthest, with 16 descendants of its own.
- 5 other devices also cite its predicate K922058.
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?
For central monitoring of adult, pediatric, and neonatal patients; and
where the clinician decides to monitor cardiac arrhythmia of adult,
pediatric, and neonatal patients and/or ST segment of adult patients
to gain information for treatment, to monitor adequacy of treatment,
or to exclude causes of symptoms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023674 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023674: Philips Drug Calculator Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023674
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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