510(k) · Cleared
ClearedUltima Airflow Pressure Sensor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Braebon Medical Corp. · BZQ Monitor, Breathing Frequency
Cleared on Dec 30, 1998 as substantially equivalent to K981445 (Braebon Medical Corp., 1998) after a 19-day review. Its family tree reaches back 1 generation to 1998. 50 later devices descend from it.
- Decided
- Dec 30, 1998
- Review
- 19 days
- Class
- Class II
- Product code
- BZQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K981445 (1998). 50 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK981445 Ultima Airflow Sensor, 0510Braebon Medical Corp. · 1998
- This deviceK984431 Ultima Airflow Pressure SensorBraebon Medical Corp. · 1998
- Descendant · cites it directly · 48 of its ownK031202 Medipalm-20Braebon Medical Corp. · 2003
- Descendant · 2 generations on · 41 of its ownK073682 Embletta GoldEmbla Systems, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 27 of its ownK122516 Embletta MPREmbla Systems · 2013 · Recalled
- Descendant · 4 generations on · 20 of its ownK161579 Watch-PAT200UItamar Medical, Ltd. · 2017
- Descendant · 5 generations on · 12 of its ownK180775 Watch-PAT300Itamar Medical, Ltd. · 2018
Showing 5 of 50 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 50 · See all- K031202Medipalm-20Braebon Medical Corp. · 2003 · cites it directly48descendants
- K073682Embletta GoldEmbla Systems, Inc. · 2008 · 2 generations on41descendants
- K122516Embletta MPREmbla Systems · 2013 · 3 generations on27descendants
- K161579Watch-PAT200UItamar Medical, Ltd. · 2017 · 4 generations on20descendants
- K180775Watch-PAT300Itamar Medical, Ltd. · 2018 · 5 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981445 | Ultima Airflow Sensor, 0510 | Braebon Medical Corp. | 1998 | — |
| 0 (this device) | K984431 | Ultima Airflow Pressure Sensor | Braebon Medical Corp. | 1998 | — |
| +1 | K031202 | Medipalm-20 | Braebon Medical Corp. | 2003 | — |
| +2 | K073682 | Embletta Gold | Embla Systems, Inc. | 2008 | 1 |
| +3 | K122516 | Embletta MPR | Embla Systems | 2013 | 1 |
| +4 | K161579 | Watch-PAT200U | Itamar Medical, Ltd. | 2017 | — |
| +5 | K180775 | Watch-PAT300 | Itamar Medical, Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 6 | 0 |
| 2023 | 5 | 0 |
| 2024 | 2 | 0 |
| 2025 | 9 | 0 |
| 2026 | 5 | 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? (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 |
|---|---|---|---|
| * | K981445 | Ultima Airflow Sensor, 0510Summary page 1…name: Airflow Pressure Sensor Classification name: Breathing frequency monitor (per CFR 868.1860) Predicate device: Ultima Airflow Sensor, Braebon Medical Corporation, k981445 Description of the Device: The Ultima Airflow Pressure Sensors, Models #0580H and #0580L, are small interface devices which con… | 1998 |
What descends from it? (50)
See all 503 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?
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?
An indicator of respiratory airflow for recording onto a data acquisition system.
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/K984431 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984431: Ultima Airflow Pressure Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984431
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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