510(k) · Cleared
ClearedBluebird Single-Use Respiratory Effort Belt
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cadwell Industries, Inc. · MNR Ventilatory Effort Recorder
Cleared on Dec 18, 2024 as substantially equivalent to K173793 (Embla Systems, 2019) after a 125-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- Dec 18, 2024
- Review
- 125 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K000068 (2000). 12 ancestors in all, the oldest K903300 (1990). No later device cites it as a predicate yet.
- Root · 5 generations backK000068 Compumedics E-Series Eeg SystemCompumedics Neuro Science Pty, Ltd. · 2000 · Recalled
- 4 generations backK021176 Compumedics Somte SystemCompumedics Limited · 2003
- 3 generations backK040194 Compumedics Summit IPCompumedics USA, Ltd. · 2004
- 2 generations backK043132 Universal XacttraceMedcare Flaga · 2004
- 1 generation backK173793 XactTrace Single Use Respiratory Effort Belt SystemEmbla Systems · 2019
- This deviceK242424 Bluebird Single-Use Respiratory Effort BeltCadwell Industries, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K000068 | Compumedics E-Series Eeg System | Compumedics Neuro Science Pty, Ltd. | 2000 | 1 |
| −4 | K021176 | Compumedics Somte System | Compumedics Limited | 2003 | — |
| −3 | K040194 | Compumedics Summit IP | Compumedics USA, Ltd. | 2004 | — |
| −2 | K043132 | Universal Xacttrace | Medcare Flaga | 2004 | — |
| −1 | K173793 | XactTrace Single Use Respiratory Effort Belt System | Embla Systems | 2019 | — |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K173793 | XactTrace Single Use Respiratory Effort Belt SystemSummary page 5…ory Effort Recorder, Breathing Frequency Monitor Class II Product Code: MNR Predicate Device 510(k) Number: K173793 Trade Name: XactTrace® Single Use Respiratory Effort Belt System Submitter Name: Natus Neurology… | 2019 |
| † | K151361 | Nox RIP Belts & Cables | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 12 ancestors has a recall of any class.
How does its category compare?
All MNR devicesMNR Ventilatory Effort Recorder: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Bluebird Single-Use Respiratory Effort Belt is intended to measure respiratory effort to assist in the diagnosis of sleep disorders or sleep related respiratory disorders. The respiratory effort belt signals are suitable for connection to sleep/polysomnography (PSG) systems. The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments, including the patient's home.
The Bluebird Single-Use Respiratory Effort Belt is intended for diagnostic purposes only on patients greater than 2 years of age and is not intended to be used as an apnea monitor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242424 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242424: Bluebird Single-Use Respiratory Effort Belt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242424
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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