510(k) · Cleared
ClearedCrystal Trace Piezo Respiratory Effort Sensor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pro-Tech, Inc. · BZQ Monitor, Breathing Frequency
Cleared on Dec 30, 1992 after a 173-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 205 later devices descend from it.
- Decided
- Dec 30, 1992
- Review
- 173 days
- Class
- Class II
- Product code
- BZQ
- Recalls
- None
- Predicates
- 0
205 later devices descend from it, 5 citing it directly.
- This deviceK923402 Crystal Trace Piezo Respiratory Effort SensorPro-Tech, Inc. · 1992
- Descendant · cites it directly · 100 of its ownK040605 Dymedix Reusable Respiratory Effort Belt Sensor, Model 6015 and…Dymedix, Inc. · 2004
- Descendant · 2 generations on · 99 of its ownK061993 Equivital, Model EQ-01Hidalgo Limited · 2006
- Descendant · cites it directly · 99 of its ownK020607 Sleepflo, Model 101501Biomec, Inc. · 2002
- Descendant · 2 generations on · 98 of its ownK030379 Aplab, Model 801D0030Sector Medical Corp. · 2003
- Descendant · 2 generations on · 71 of its ownK113054 EquivitalHidalgo Limited · 2012
Showing 5 of 205 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 205 · See all- K040605Dymedix Reusable Respiratory Effort Belt Sensor, Model 6015 and Dymedix Reusable Limb…Dymedix, Inc. · 2004 · cites it directly100descendants
- K061993Equivital, Model EQ-01Hidalgo Limited · 2006 · 2 generations on99descendants
- K020607Sleepflo, Model 101501Biomec, Inc. · 2002 · cites it directly99descendants
- K030379Aplab, Model 801D0030Sector Medical Corp. · 2003 · 2 generations on98descendants
- K113054EquivitalHidalgo Limited · 2012 · 2 generations on71descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K923402 | Crystal Trace Piezo Respiratory Effort Sensor | Pro-Tech, Inc. | 1992 | — |
| +1 | K040605 | Dymedix Reusable Respiratory Effort Belt Sensor, Model 6015 and Dymedix… | Dymedix, Inc. | 2004 | — |
| +2 | K061993 | Equivital, Model EQ-01 | Hidalgo Limited | 2006 | — |
| +1 | K020607 | Sleepflo, Model 101501 | Biomec, Inc. | 2002 | — |
| +2 | K030379 | Aplab, Model 801D0030 | Sector Medical Corp. | 2003 | — |
| +2 | K113054 | Equivital | Hidalgo Limited | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 5 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 4 | 0 |
| 2013 | 7 | 0 |
| 2014 | 4 | 0 |
| 2015 | 6 | 0 |
| 2016 | 7 | 0 |
| 2017 | 9 | 0 |
| 2018 | 9 | 0 |
| 2019 | 17 | 0 |
| 2020 | 14 | 0 |
| 2021 | 8 | 0 |
| 2022 | 15 | 0 |
| 2023 | 18 | 0 |
| 2024 | 16 | 0 |
| 2025 | 29 | 0 |
| 2026 | 18 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (205)
See all 2055 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040605 | Dymedix Reusable Respiratory Effort Belt Sensor, Model 6015 and Dymedix Reusable Limb… | 2004 | 100 |
| K020607 | Sleepflo, Model 101501 | 2002 | 99 |
| K043132 | Universal Xacttrace | 2004 | 10 |
| K173793 | XactTrace Single Use Respiratory Effort Belt System | 2019 | 1 |
| K983449 | Gereonics Ultra-Piezo Respiratory Effort Sensor | 1999 | 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?
- Of its descendants, K040605 (Dymedix, Inc., 2004) has gone furthest, with 100 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/K923402 · printed Nov 6, 2026
Cite this page
510(k) Report. “K923402: Crystal Trace Piezo Respiratory Effort Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K923402
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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