510(k) · Cleared
Recalled · 2004Trio Monitor Model 0998-00-0600
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datascope Corp. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Feb 11, 2004 after a 197-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Feb 11, 2004
- Review
- 197 days
- Class
- Class II
- Product code
- MWI
- Recalls
- 2
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK032338 Trio Monitor Model 0998-00-0600Datascope Corp. · 2004
- Descendant · cites it directly · 0 of its ownK041907 Trio MonitorDatascope Corp. · 2004
Most influential descendants
Showing 1 of 1 · See all- K041907Trio MonitorDatascope Corp. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032338 | Trio Monitor Model 0998-00-0600 | Datascope Corp. | 2004 | — |
| +1 | K041907 | Trio Monitor | Datascope Corp. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 MWI? 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 MWI device
- #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | GE Medical Systems Dash 2000 Pro Patient Monitor Named without a submission number |
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 |
|---|---|---|---|
| K041907 | Trio Monitor | 2004 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 24, 2004 | Not classified | Z-0018-05 | Other | Software anomaly where the variable heart rates may be displayed inaccurately or intermittent 'dashes' may be displayed when the patient's heart rate is derived from ECG. |
| Jul 28, 2004 | Not classified | Z-1483-04 | Other | The Trio Monitor has latex feet. It is not labeled per 21 CFR801.437 to indicate that it contains latex. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K041907 (Datascope Corp., 2004) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MWI devicesMWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MWI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWI
247in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWI
9so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWI
182in 2025
MAUDE reports naming product code MWI, 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 | 9 | 42 | 1 | 3 |
| 2008 | 9 | 49 | 1 | 3 |
| 2009 | 6 | 112 | 2 | 20 |
| 2010 | 17 | 58 | 2 | 17 |
| 2011 | 11 | 78 | 3 | 16 |
| 2012 | 13 | 104 | 5 | 31 |
| 2013 | 20 | 85 | 3 | 42 |
| 2014 | 16 | 148 | 6 | 30 |
| 2015 | 19 | 127 | 1 | 31 |
| 2016 | 12 | 165 | 0 | 51 |
| 2017 | 13 | 205 | 2 | 85 |
| 2018 | 11 | 217 | 0 | 158 |
| 2019 | 14 | 255 | 4 | 169 |
| 2020 | 8 | 138 | 0 | 110 |
| 2021 | 9 | 161 | 0 | 188 |
| 2022 | 5 | 231 | 2 | 168 |
| 2023 | 8 | 250 | 0 | 179 |
| 2024 | 10 | 202 | 5 | 120 |
| 2025 | 4 | 247 | 0 | 182 |
| 2026 | 6 | 239 | 9 | — |
What is it indicated for?
The TrioTM monitor is intended for hospital use under the direct supervision of a licensed healthcare practitioner. The intended use of the monitor is to monitor physiologic parameter data on adult and pediatric patients. Physiologic data includes: electrocardiogram, invasive blood pressure, noninvasive blood pressure, pulse oximetry, heart rate (derived from ECG or SpO2), respiration and temperature as summarized in the operating instructions manual. The information can be displayed, stored, trended and printed.
The monitor is not intended for home use. The monitor is not intended to be an apnea monitor. It was not designed or validated for use as an apnea monitor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032338 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032338: Trio Monitor Model 0998-00-0600.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032338
Report an extraction error
Are you the manufacturer?
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