510(k) · Cleared
ClearedUniversal Xacttrace
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medcare Flaga · MNR Ventilatory Effort Recorder
Cleared on Dec 21, 2004 as substantially equivalent to K923402 (Pro-Tech, Inc., 1992) and 1 other predicate after a 39-day review. Its family tree reaches back 3 generations to 2000. 10 later devices descend from it.
- Decided
- Dec 21, 2004
- Review
- 39 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K000068 (2000). 6 ancestors in all, the oldest K923402 (1992). 10 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK000068 Compumedics E-Series Eeg SystemCompumedics Neuro Science Pty, Ltd. · 2000 · Recalled
- 2 generations backK021176 Compumedics Somte SystemCompumedics Limited · 2003
- 1 generation backK040194 Compumedics Summit IPCompumedics USA, Ltd. · 2004
- This deviceK043132 Universal XacttraceMedcare Flaga · 2004
- Descendant · cites it directly · 7 of its ownK090273 Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai…Kai Sensors, Inc. · 2009
- Descendant · 2 generations on · 3 of its ownK151940 Thora-3Di, Model T-01Pneumacare Limited · 2016
- Descendant · 3 generations on · 2 of its ownK242001 Philips VSC-MEDlibPhilips Medical Systems Nederland B.V. · 2025
- Descendant · 4 generations on · 1 of its ownK243966 FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)Faceheart Corp. · 2025
- Descendant · cites it directly · 1 of its ownK173793 XactTrace Single Use Respiratory Effort Belt SystemEmbla Systems · 2019
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K090273Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai Rspot, Model 100Kai Sensors, Inc. · 2009 · cites it directly7descendants
- K151940Thora-3Di, Model T-01Pneumacare Limited · 2016 · 2 generations on3descendants
- K242001Philips VSC-MEDlibPhilips Medical Systems Nederland B.V. · 2025 · 3 generations on2descendants
- K243966FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)Faceheart Corp. · 2025 · 4 generations on1descendant
- K173793XactTrace Single Use Respiratory Effort Belt SystemEmbla Systems · 2019 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000068 | Compumedics E-Series Eeg System | Compumedics Neuro Science Pty, Ltd. | 2000 | 1 |
| −2 | K021176 | Compumedics Somte System | Compumedics Limited | 2003 | — |
| −1 | K040194 | Compumedics Summit IP | Compumedics USA, Ltd. | 2004 | — |
| 0 (this device) | K043132 | Universal Xacttrace | Medcare Flaga | 2004 | — |
| +1 | K090273 | Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai Rspot… | Kai Sensors, Inc. | 2009 | — |
| +2 | K151940 | Thora-3Di, Model T-01 | Pneumacare Limited | 2016 | — |
| +3 | K242001 | Philips VSC-MEDlib | Philips Medical Systems Nederland B.V. | 2025 | — |
| +4 | K243966 | FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) | Faceheart Corp. | 2025 | — |
| +1 | K173793 | XactTrace Single Use Respiratory Effort Belt System | Embla Systems | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 MNR? 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 MNR device
- #1 K244027 Sansa Hsatscore 18.1 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K923402 | Crystal Trace Piezo Respiratory Effort SensorSummary page 1…anel: Anesthesiology Predicate Devices Crystal Trace Piezo Respiratory Effort Sensor from Pro -Tech Product Code: BZQ 510(k) Number: K923402 Summit IP from Compumedics USA Product Code: MNR 510(k) Number: K040194 Medoare Flaga · Sidum.li… | 1992 |
| * | K040194 | Compumedics Summit IPSummary page 1…sor from Pro -Tech Product Code: BZQ 510(k) Number: K923402 Summit IP from Compumedics USA Product Code: MNR 510(k) Number: K040194 Medoare Flaga · Sidum.li 24 · 108 Reykjavik · Iceland· phone +354 510 2000 * fax +354 510 2010 · W'wrmedCareC.m… | 2004 |
What descends from it? (10)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K090273 (Kai Sensors, Inc., 2009) has gone furthest, with 7 descendants of its own.
- 4 other devices also cite its predicate K923402.
How does its category compare?
All MNR devicesMNR Ventilatory Effort Recorder: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNR
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MNR
165in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNR
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNR
43in 2025
MAUDE reports naming product code MNR, 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 | 6 | 124 | 2 | 1 |
| 2008 | 14 | 118 | 0 | 0 |
| 2009 | 8 | 89 | 1 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 9 | 90 | 1 | 1 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 4 | 161 | 0 | 0 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 4 | 229 | 0 | 4 |
| 2016 | 3 | 281 | 0 | 10 |
| 2017 | 4 | 275 | 0 | 4 |
| 2018 | 3 | 147 | 0 | 2 |
| 2019 | 8 | 383 | 0 | 3 |
| 2020 | 5 | 192 | 0 | 5 |
| 2021 | 3 | 137 | 1 | 5 |
| 2022 | 7 | 266 | 0 | 4 |
| 2023 | 6 | 183 | 0 | 13 |
| 2024 | 6 | 217 | 0 | 11 |
| 2025 | 10 | 165 | 0 | 43 |
| 2026 | 5 | 227 | 1 | — |
What is it indicated for?
Universal XactTrace is intended to measure respiratory effort to assist in the diagnosis of sleep disorders or sleep related respiratory disorders. The respiratory effort signals measured are processed to provide electrical signals suitable for connection to the inputs of physiological recording equipment.
The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments.
Universal XactTrace is intended for diagnostics purposes only and is not intended to be used as an apnea monitor.
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/K043132 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043132: Universal Xacttrace.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043132
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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