510(k) · Cleared
Recalled · 2003Modification to: Datex-Ohmeda Cardiocap 5 (Rev B) and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datex-Ohmeda · MLD Monitor, St Segment With Alarm
Cleared on Sep 14, 2001 as substantially equivalent to K992323 (Datex-Ohmeda, Inc., 1999) after a 22-day review. Its family tree reaches back 1 generation to 1999. It has been recalled 2 times.
- Decided
- Sep 14, 2001
- Review
- 22 days
- Class
- Class II
- Product code
- MLD
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K992323 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK992323 Datex-Ohmeda Cardiocap 5, F-MX, F-MXG and AccessoriesDatex-Ohmeda, Inc. · 1999 · Recalled
- This deviceK012837 Modification to: Datex-Ohmeda Cardiocap 5 (Rev B) and AccessoriesDatex-Ohmeda · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992323 | Datex-Ohmeda Cardiocap 5, F-MX, F-MXG and Accessories | Datex-Ohmeda, Inc. | 1999 | 1 |
| 0 (this device) | K012837 | Modification to: Datex-Ohmeda Cardiocap 5 (Rev B) and Accessories | Datex-Ohmeda | 2001 | — |
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 MLD? 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? (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 |
|---|---|---|---|
| * | K992323 | Datex-Ohmeda Cardiocap 5, F-MX, F-MXG and AccessoriesSummary page 2…x-Ohmeda Cardiocap 5 Rev B and accessories is substantially equivalent ) in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda Cardiocap 5 Rev A (K992323). DEVICE DESCRIPTION as required by 807.92(a)(4) The Cardiocap 5 monitor is a multi-parameter monitor that is factory configure… | 1999 |
| † | K974747 | CS/3 Arrhythmia Workstation | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 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. |
| Sep 16, 2002 | Not classified | Z-0611-03 | Other | Falsely high blood oxygen saturation readings in some circumstances which could result in no alarm in a critical life-threatening situation. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 1 other device also cites its predicate K992323.
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 (REV. B) and accessories are 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 hospital patients. With the N-XOSAT option, monitoring of arterial oxygen saturation includes monitoring…
Read the full statement (102 words)
The Datex-Ohmeda Cardiocap 5 (REV. B) and accessories are 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 hospital patients.
With the N-XOSAT option, monitoring of arterial oxygen saturation includes monitoring hospital patients under clinical motion conditions.
Impedance Respiration measurement is indicated for patients ages 3 years and older. Cardiocap/5 is indicated for patients weighing 5 kg (11 Ib.) or more.
The monitor is indicated for use by qualified medical personnel only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012837 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012837: Modification to: Datex-Ohmeda Cardiocap 5 (Rev B) and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012837
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026