510(k) · Cleared
ClearedGereonics Ultra-Piezo Respiratory Effort Sensor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gereonics, Inc. · BZQ Monitor, Breathing Frequency
Cleared on Feb 8, 1999 as substantially equivalent to K923402 (Pro-Tech, Inc., 1992) after a 131-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Feb 8, 1999
- Review
- 131 days
- Class
- Class II
- Product code
- BZQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K923402 (1992). No later device cites it as a predicate yet.
- Root · 1 generation backK923402 Crystal Trace Piezo Respiratory Effort SensorPro-Tech, Inc. · 1992
- This deviceK983449 Gereonics Ultra-Piezo Respiratory Effort SensorGereonics, Inc. · 1999
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) | K983449 | Gereonics Ultra-Piezo Respiratory Effort Sensor | Gereonics, Inc. | 1999 | — |
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? (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 |
|---|---|---|---|
| * | K923402 | Crystal Trace Piezo Respiratory Effort SensorSummary page 2…tion and function to at least two devices currently on the market. 1. The system is most similar to a device manufactured and sold by Pro-Tech, Inc. The 510(k) Number is K923402, Decision Date 12/30/92. 2. Another firm marketing a similar product is: EPMS, Inc. 5212 Highberry Woods Road Midlothian, Virgin… | 1992 |
| † | K903300 | Resp-EZ (TM) Respiratory Monitoring Belt | 1990 |
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?
- Its one ancestor has no recall.
- 4 other devices also cite its predicate K923402.
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 Gereonics Ultra-Piezo Respiratory Effort Sensor is intended for use in sleep disorders studies to measure respiratory effort for monitoring or recording on a physiological recording system.
The Ultra-Piezo Respiratory Effort Sensor is NOT intended for use as an Apnea Alarm.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983449 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983449: Gereonics Ultra-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/K983449
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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