510(k) · Cleared
ClearedRespitrace Plus, Respibands, and Respicentral
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Non-Invasive Monitoring Systems, Inc. · BZQ Monitor, Breathing Frequency
Cleared on Mar 29, 1991 after a 263-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Mar 29, 1991
- Review
- 263 days
- Class
- Class II
- Product code
- BZQ
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK903011 Respitrace Plus, Respibands, and RespicentralNon-Invasive Monitoring Systems, Inc. · 1991
- Descendant · cites it directly · 3 of its ownK124062 QDC-Pro, and Nox-RipNox Medical · 2013
- Descendant · 2 generations on · 2 of its ownK151361 Nox RIP Belts & CablesNox Medical Ehf · 2015
- Descendant · 3 generations on · 0 of its ownK260949 Disposable Belts for Polysomnography (CNSAC)CNSAC Medshop GmbH · 2026
- Descendant · 3 generations on · 0 of its ownK171304 Maxxi Rip SensorNeurovirtual USA, Inc. · 2019
Most influential descendants
Showing 4 of 4 · See all- K124062QDC-Pro, and Nox-RipNox Medical · 2013 · cites it directly3descendants
- K151361Nox RIP Belts & CablesNox Medical Ehf · 2015 · 2 generations on2descendants
- K260949Disposable Belts for Polysomnography (CNSAC)CNSAC Medshop GmbH · 2026 · 3 generations on0descendants
- K171304Maxxi Rip SensorNeurovirtual USA, Inc. · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K903011 | Respitrace Plus, Respibands, and Respicentral | Non-Invasive Monitoring Systems, Inc. | 1991 | — |
| +1 | K124062 | QDC-Pro, and Nox-Rip | Nox Medical | 2013 | — |
| +2 | K151361 | Nox RIP Belts & Cables | Nox Medical Ehf | 2015 | — |
| +3 | K260949 | Disposable Belts for Polysomnography (CNSAC) | CNSAC Medshop GmbH | 2026 | — |
| +3 | K171304 | Maxxi Rip Sensor | Neurovirtual USA, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BZQ? 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 BZQ device
- #1 K251326 Respiration Rate algorithmscore 20.2 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K124062 | QDC-Pro, and Nox-Rip | 2013 | 3 |
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?
- Of its descendants, K124062 (Nox Medical, 2013) has gone furthest, with 3 descendants of its own.
How does its category compare?
All BZQ devicesBZQ Monitor, Breathing Frequency: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BZQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BZQ
255in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZQ
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BZQ
2in 2022
MAUDE reports naming product code BZQ, 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 | 2 | — | 0 | 7 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 3 | 121 | 0 | 1 |
| 2010 | 2 | — | 1 | 1 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 3 |
| 2013 | 3 | 261 | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 11 |
| 2018 | 3 | 198 | 0 | 10 |
| 2019 | 1 | — | 0 | 13 |
| 2020 | 2 | — | 0 | 10 |
| 2021 | 2 | — | 0 | 1 |
| 2022 | 3 | 198 | 0 | 2 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 7 | 255 | 0 | 0 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K903011 · printed Nov 6, 2026
Cite this page
510(k) Report. “K903011: Respitrace Plus, Respibands, and Respicentral.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K903011
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026