510(k) · Cleared
Recalled · 2003Datex-Ohmeda Cardiocap 5, F-MX, F-MXG and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datex-Ohmeda, Inc. · MLD Monitor, St Segment With Alarm
Cleared on Nov 1, 1999 after a 112-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 of the 5 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it. It has been recalled once.
- Decided
- Nov 1, 1999
- Review
- 112 days
- Class
- Class II
- Product code
- MLD
- Recalls
- 1
- Predicates
- 0
4 later devices descend from it, 2 citing it directly. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- This deviceK992323 Datex-Ohmeda Cardiocap 5, F-MX, F-MXG and AccessoriesDatex-Ohmeda, Inc. · 1999
- Descendant · cites it directly · 2 of its ownK093881 Trusignal SPO2 Finger Sensor, Trusignal SPO2 Ear Sensor, Trusignal…GE Healthcare Finland Oy · 2010 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK250931 Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117)…Unimed Medical Supplies, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK132696 Trusignal SPO2 Adult and Pediatric Adhesive Wrap Disposable SensorGE Healthcare Finland Oy · 2013
- Descendant · cites it directly · 0 of its ownK012837 Modification to: Datex-Ohmeda Cardiocap 5 (Rev B) and AccessoriesDatex-Ohmeda · 2001 · Recalled
Class I recalls in this family
- K093881 Trusignal SPO2 Finger Sensor, Trusignal SPO2 Ear…cites it directly · 2010
Most influential descendants
Showing 4 of 4 · See all- K093881Trusignal SPO2 Finger Sensor, Trusignal SPO2 Ear Sensor, Trusignal SPO2 Wrap SensorGE Healthcare Finland Oy · 2010 · cites it directly2descendants
- K250931Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2…Unimed Medical Supplies, Inc. · 2025 · 2 generations on0descendants
- K132696Trusignal SPO2 Adult and Pediatric Adhesive Wrap Disposable SensorGE Healthcare Finland Oy · 2013 · 2 generations on0descendants
- K012837Modification to: Datex-Ohmeda Cardiocap 5 (Rev B) and AccessoriesDatex-Ohmeda · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992323 | Datex-Ohmeda Cardiocap 5, F-MX, F-MXG and Accessories | Datex-Ohmeda, Inc. | 1999 | — |
| +1 | K093881 | Trusignal SPO2 Finger Sensor, Trusignal SPO2 Ear Sensor, Trusignal SPO2 Wrap… | GE Healthcare Finland Oy | 2010 | Class I |
| +2 | K250931 | Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed… | Unimed Medical Supplies, Inc. | 2025 | — |
| +2 | K132696 | Trusignal SPO2 Adult and Pediatric Adhesive Wrap Disposable Sensor | GE Healthcare Finland Oy | 2013 | — |
| +1 | K012837 | Modification to: Datex-Ohmeda Cardiocap 5 (Rev B) and Accessories | Datex-Ohmeda | 2001 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2010 | 1 | 1 |
| 2013 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 17, 2003 | Not classified | Z-0143-04 | Other | Datex-Ohmeda Cardiocap/5 Patient Monitors have bracket pins which do not adequately secure them to their optional mounting stand so the monitors may fall. |
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.
- K093881Trusignal SPO2 Finger Sensor, Trusignal SPO2 Ear Sensor, Trusignal SPO2 Wrap SensorGE Healthcare Finland Oy · 2010 · Cites it directly · ◆ in the 2010 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- Of its descendants, K093881 (GE Healthcare Finland Oy, 2010) has gone furthest, with 2 descendants of its own.
How does its category compare?
All MLD devicesMLD Monitor, St Segment With Alarm: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MLD
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · MLD
Too few MLD 510(k)s in any year since 2007 to give a median.
Recalls per year · MLD
No recall names MLD since 2007.
Adverse event reports per year · MLD
1in 2019
MAUDE reports naming product code MLD, 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 | 0 | — | 0 | 3 |
| 2008 | 1 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Datex-Ohmeda Cardiocap 5 (Models F-MX, F-MXG) and accessories is indicated for indoor monitoring of hemodynamic (ECG, Impedance respiration, NIBP, Temperature, SPO2 and invasive pressure), respiratory (CO2, 02, N20, respiration rate, anesthetic agent and agent identification), ventilatory (airway pressure, volume and flow) and relaxation status (NMT) of all huspital patients.
Impedance Respiration measurement is indicated for patients ages 3 and up. Cardiocap 5 is indicated for patients with weight from 5 kg (11 1b.) up.
The monitor is indicated for usc by qualified medical personnel! only.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992323 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992323: Datex-Ohmeda Cardiocap 5, F-MX, F-MXG and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992323
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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