510(k) · Cleared
ClearedXactTrace Single Use Respiratory Effort Belt System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Embla Systems · MNR Ventilatory Effort Recorder
Cleared on Mar 1, 2019 as substantially equivalent to K043132 (Medcare Flaga, 2004) and 2 other predicates after a 442-day review. Its family tree reaches back 4 generations to 2000. 1 later device descends from it.
- Decided
- Mar 1, 2019
- Review
- 442 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K000068 (2000). 11 ancestors in all, the oldest K903300 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK000068 Compumedics E-Series Eeg SystemCompumedics Neuro Science Pty, Ltd. · 2000 · Recalled
- 3 generations backK021176 Compumedics Somte SystemCompumedics Limited · 2003
- 2 generations backK040194 Compumedics Summit IPCompumedics USA, Ltd. · 2004
- 1 generation backK043132 Universal XacttraceMedcare Flaga · 2004
- This deviceK173793 XactTrace Single Use Respiratory Effort Belt SystemEmbla Systems · 2019
- Descendant · cites it directly · 0 of its ownK242424 Bluebird Single-Use Respiratory Effort BeltCadwell Industries, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K242424Bluebird Single-Use Respiratory Effort BeltCadwell Industries, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000068 | Compumedics E-Series Eeg System | Compumedics Neuro Science Pty, Ltd. | 2000 | 1 |
| −3 | K021176 | Compumedics Somte System | Compumedics Limited | 2003 | — |
| −2 | K040194 | Compumedics Summit IP | Compumedics USA, Ltd. | 2004 | — |
| −1 | K043132 | Universal Xacttrace | Medcare Flaga | 2004 | — |
| 0 (this device) | K173793 | XactTrace Single Use Respiratory Effort Belt System | Embla Systems | 2019 | — |
| +1 | K242424 | Bluebird Single-Use Respiratory Effort Belt | Cadwell Industries, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (3)
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 |
|---|---|---|---|
| * | K043132 | Universal XacttraceSummary page 4…me: 21 CFR 868.2375, Ventilatory Effort Recorder Class II Product Code: MNR Predicate Device(s) 510(k) Number: K043132 (Primary Predicate) K923402 Trade Name: Universal XactTrace Crystal Trac… | 2004 |
| * | K923402 | Crystal Trace Piezo Respiratory Effort SensorSummary page 4…Recorder Class II Product Code: MNR Predicate Device(s) 510(k) Number: K043132 (Primary Predicate) K923402 Trade Name: Universal XactTrace Crystal Trace Piezo Respiratory Effort Sensor Submitter N… | 1992 |
| * | K042253 | Sleepsense Sleep SensorsSummary page 4…monitor monitor Product Code: MNR BZQ 510(k) Number: K042253 Trade Name: SleepSense Sleep Sensors Submitter Name: SLP Ltd. Classification Name: 21 CFR 868.237… | 2004 |
| † | K024322 | Embla N7000 | 2003 |
| † | K041724 | Compass M10 System | 2004 |
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 |
|---|---|---|---|
| K242424 | Bluebird Single-Use Respiratory Effort Belt | 2024 | 0 |
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 19 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K242424 (Cadwell Industries, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K043132.
How does its category compare?
All MNR devicesMNR Ventilatory Effort Recorder: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
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?
The XactTrace® Single Use Respiratory Effort Belt System 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.
The XactTrace® Single Use Respiratory Effort Belt System is intended for diagnostics purposes only and is not intended to be used as an apnea monitor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173793 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173793: XactTrace Single Use Respiratory Effort Belt System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173793
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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