510(k) · Cleared
Recalled · Class I · 2014Datex-Ohmeda S/5TM FM with L-FICU04 and L-FICU04A Software and N-Fcrec Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datex-Ohmeda · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Dec 23, 2004 as substantially equivalent to K022740 (Datex-Ohmeda, 2002) and 3 other predicates after a 27-day review. Its family tree reaches back 2 generations to 2000. 2 of the 18 devices in its family, counting itself, have a Class I recall. 11 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Dec 23, 2004
- Review
- 27 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 1 (1 Class I)
- Predicates
- 4
Its longest line of descent runs back 2 generations to K002158 (2000). 6 ancestors in all, the oldest K933285 (1994). 11 later devices descend from it, 1 citing it directly. 2 of the 18 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK002158 S/5 Compact Critical Care Monitor with S-00C03 or S-00C04 SoftwareDatex-Ohmeda, Inc. · 2000
- 1 generation backK022740 Datex-Ohmeda S/5 Compact Critical Care Monitor with L-CICU02 &…Datex-Ohmeda · 2002 · Recalled
- This deviceK043276 Datex-Ohmeda S/5TM FM with L-FICU04 and L-FICU04A Software and…Datex-Ohmeda · 2004
- Descendant · cites it directly · 10 of its ownK120598 Procare Monitor B40Ge Medical Systems China Co., Ltd. · 2012 · Recalled
- Descendant · 2 generations on · 8 of its ownK130584 Monitor B40Ge Medical Systems China Co., Ltd. · 2013 · Recalled
- Descendant · 3 generations on · 7 of its ownK133576 Monitor B40Ge Medical Systems China Co., Ltd. · 2014 · Recalled (Class I)
- Descendant · 4 generations on · 5 of its ownK151063 Monitor B40Ge Medical Systems China Co., Ltd. · 2015 · Recalled
- Descendant · 5 generations on · 4 of its ownK171580 Monitor B125, Monitor B105Ge Medical Systems (China) Co., Ltd. · 2017 · Recalled
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K133576 Monitor B403 generations on · 2014
Most influential descendants
Showing 5 of 11 · See all- K120598Procare Monitor B40Ge Medical Systems China Co., Ltd. · 2012 · cites it directly10descendants
- K130584Monitor B40Ge Medical Systems China Co., Ltd. · 2013 · 2 generations on8descendants
- K133576Monitor B40Ge Medical Systems China Co., Ltd. · 2014 · 3 generations on7descendants
- K151063Monitor B40Ge Medical Systems China Co., Ltd. · 2015 · 4 generations on5descendants
- K171580Monitor B125, Monitor B105Ge Medical Systems (China) Co., Ltd. · 2017 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002158 | S/5 Compact Critical Care Monitor with S-00C03 or S-00C04 Software | Datex-Ohmeda, Inc. | 2000 | — |
| −1 | K022740 | Datex-Ohmeda S/5 Compact Critical Care Monitor with L-CICU02 & L-CICU02A… | Datex-Ohmeda | 2002 | 2 |
| 0 (this device) | K043276 | Datex-Ohmeda S/5TM FM with L-FICU04 and L-FICU04A Software and N-Fcrec Module | Datex-Ohmeda | 2004 | — |
| +1 | K120598 | Procare Monitor B40 | Ge Medical Systems China Co., Ltd. | 2012 | 2 |
| +2 | K130584 | Monitor B40 | Ge Medical Systems China Co., Ltd. | 2013 | 2 |
| +3 | K133576 | Monitor B40 | Ge Medical Systems China Co., Ltd. | 2014 | Class I |
| +4 | K151063 | Monitor B40 | Ge Medical Systems China Co., Ltd. | 2015 | 1 |
| +5 | K171580 | Monitor B125, Monitor B105 | Ge Medical Systems (China) Co., Ltd. | 2017 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 1 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 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.
2 devices in this family have 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? (4)
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 |
|---|---|---|---|
| * | K022740 | Datex-Ohmeda S/5 Compact Critical Care Monitor with L-CICU02 & L-CICU02A SoftwareSummary page 2…nd L- FICU04A software is substantially equivalent to the predicate Datex-Ohmeda S/5 TM Compact Critical Care Monitor with L-CICU02 and L-CICU02A software (K022740). The N-F(C)(REC) Extension module used with the FM Monitor allows measuring C02 (module versions N-FC and N-FCREC) and pr… | 2002 |
| * | K023454 | Datex-Ohmeda S/5 Single-Width Airway Module M-Minic and AccessoriesSummary page 2…recorder chart (module versions N-FREC and N-FCREC). The C02 measurement of the N-FC(REC) is based on the C02 measurement of the predicate M-miniC module (K023454). The recorder option is based on the predicate M-REC module, originally cleared in the Datex AS/3 AM Monitor (K933… | 2003 |
| * | K933285 | Datex as/3 TM Anaesthesia MonitorSummary page 2…ent of the predicate M-miniC module (K023454). The recorder option is based on the predicate M-REC module, originally cleared in the Datex AS/3 AM Monitor (K933285) and the Datex AS/3 Compact Monitor (K933156) submissions. DEVICE DESCRIPTION as required by 807.92(a)(4) The S/5TM FM… | 1994 |
| * | K933156 | Datex as/3 Patient MonitorSummary page 2…. The recorder option is based on the predicate M-REC module, originally cleared in the Datex AS/3 AM Monitor (K933285) and the Datex AS/3 Compact Monitor (K933156) submissions. DEVICE DESCRIPTION as required by 807.92(a)(4) The S/5TM FM Monitor with L-FICU04(A) software is a patie… | 1994 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120598 | Procare Monitor B40 | 2012 | 10 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 11, 2014 | Class I | Z-2068-2014 | Device Design | Failure of the CO2 detector in Single-width Airway and Extension modules, which may cause a slow continuous decrease of measured Et-/FiCO2 values. Incorrect Et CO2/Fi CO2 value may impair clinical decision making for both mechanically and… |
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 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K120598 (Ge Medical Systems China Co., Ltd., 2012) has gone furthest, with 10 descendants of its own.
- 1 other device also cites its predicate K022740.
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 S/5 FM with L-FICU04 or L-FICU04A software is indicated for monitoring
of hemodynamics (including arrhythmia and ST-segment analysis) and
respiratory status of all hospital patients.
Extension module N-FCREC (option N-FCREC or N-FC) is indicated for
monitoring C02 and respiration rate of all hospital patients. C02
measurements are indicated for patients weighing over 5kg (11 lbs).
The S/5 FM Monitor and N-F(C)(REC) Extension Module are indicated for use
by qualified medical personnel only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043276 · printed Nov 3, 2026
Cite this page
510(k) Report. “K043276: Datex-Ohmeda S/5TM FM with L-FICU04 and L-FICU04A Software and N-Fcrec Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K043276
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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