510(k) · Cleared
ClearedDymedix Reusable Respiratory Effort Belt Sensor, Model 6015 and Dymedix Reusable Limb Movement Sensor, Model 3100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dymedix, Inc. · BZQ Monitor, Breathing Frequency
Cleared on Apr 26, 2004 as substantially equivalent to K001030 (Dymedix, Inc., 2000) and 2 other predicates after a 49-day review. Its family tree reaches back 1 generation to 1992. 100 later devices descend from it.
- Decided
- Apr 26, 2004
- Review
- 49 days
- Class
- Class II
- Product code
- BZQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K923402 (1992). 3 ancestors in all. 100 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK923402 Crystal Trace Piezo Respiratory Effort SensorPro-Tech, Inc. · 1992
- This deviceK040605 Dymedix Reusable Respiratory Effort Belt Sensor, Model 6015 and…Dymedix, Inc. · 2004
- Descendant · cites it directly · 99 of its ownK061993 Equivital, Model EQ-01Hidalgo Limited · 2006
- Descendant · cites it directly · 71 of its ownK113054 EquivitalHidalgo Limited · 2012
- Descendant · 2 generations on · 70 of its ownK141167 Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay…Vitalconnect, Inc. · 2014
- Descendant · 3 generations on · 43 of its ownK152139 Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc. · 2015
- Descendant · 2 generations on · 22 of its ownK081140 VisensiaObs Medical · 2008
Showing 5 of 100 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 100 · See all- K061993Equivital, Model EQ-01Hidalgo Limited · 2006 · cites it directly99descendants
- K113054EquivitalHidalgo Limited · 2012 · cites it directly71descendants
- K141167Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software Library and…Vitalconnect, Inc. · 2014 · 2 generations on70descendants
- K152139Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc. · 2015 · 3 generations on43descendants
- K081140VisensiaObs Medical · 2008 · 2 generations on22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923402 | Crystal Trace Piezo Respiratory Effort Sensor | Pro-Tech, Inc. | 1992 | — |
| 0 (this device) | K040605 | Dymedix Reusable Respiratory Effort Belt Sensor, Model 6015 and Dymedix… | Dymedix, Inc. | 2004 | — |
| +1 | K061993 | Equivital, Model EQ-01 | Hidalgo Limited | 2006 | — |
| +1 | K113054 | Equivital | Hidalgo Limited | 2012 | — |
| +2 | K141167 | Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software… | Vitalconnect, Inc. | 2014 | — |
| +3 | K152139 | Vital Connect Platform, HealthPatch MD, VitalPatch | Vitalconnect, Inc. | 2015 | — |
| +2 | K081140 | Visensia | Obs Medical | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 5 | 0 |
| 2018 | 5 | 0 |
| 2019 | 9 | 0 |
| 2020 | 8 | 0 |
| 2021 | 4 | 0 |
| 2022 | 8 | 0 |
| 2023 | 13 | 0 |
| 2024 | 12 | 0 |
| 2025 | 15 | 0 |
| 2026 | 8 | 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 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? (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 |
|---|---|---|---|
| * | K001030 | Respiratory Belt Sensor, Model 6000S; Limb Movement Sensor, Model 3000SSummary page 1…21 CFR 868.2375, Breathing Frequency Monitor, Class II, BZQ. Predicate Device(s): 510(k) Numnber: K001030 Manufacture: DYMEDIX Inc. Trade Namne… | 2000 |
| * | K923402 | Crystal Trace Piezo Respiratory Effort SensorSummary page 1…ort Belt Sensor, Periodic Limb Movement Sensor 5 10(k) Numrber: K923402 Manufacture: Pro-Tech, Inc. Trade Name… | 1992 |
| * | K940014 | PLM Sensor, Model PLM1Summary page 1…Trade Name: Crystal Trace Piezo Respiratory Effort Sensor 5 10(k) Number: K940014 Manufacture: Pro-Tech, Inc. Trade Name… | 1994 |
What descends from it? (100)
See all 1002 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?
- None of the 3 ancestors has a recall.
- Of its descendants, K061993 (Hidalgo Limited, 2006) has gone furthest, with 99 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 | — |
What is it indicated for?
The DYMEDIX, Inc. Reusable Respiratory Effort Belt Sensor and Reusable Limb Movement Sensor are used with existing sleep study recording devices in support of diagnostic recording of respiratory effort and limb movement. The sensors are used with patients who require a sleep study recording.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040605 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040605: Dymedix Reusable Respiratory Effort Belt Sensor, Model 6015 and Dymedix Reusable Limb Movement Sensor, Model 3100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040605
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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