510(k) · Cleared
ClearedWright Respirometer, Mark 8, and 14 Respirometer, Model 700-021, 700-008, 700-014
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nspire Health, Inc. · BZK Spirometer, Monitoring (W/Wo Alarm)
Cleared on Sep 21, 2009 after a 90-day review. The FDA summary names its predicate without a number. 9 later devices descend from it.
- Decided
- Sep 21, 2009
- Review
- 90 days
- Class
- Class II
- Product code
- BZK
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 1 citing it directly.
- This deviceK091853 Wright Respirometer, Mark 8, and 14 Respirometer, Model 700-021…Nspire Health, Inc. · 2009
- Descendant · cites it directly · 8 of its ownK120087 ExspironRespiratory Motion, Inc. · 2012
- Descendant · 2 generations on · 4 of its ownK130170 Exspiron 1XIRespiratory Motion, Inc. · 2013
- Descendant · 3 generations on · 3 of its ownK162131 ExSpiron 1XiRespiratory Motion, Inc. · 2017
- Descendant · 2 generations on · 2 of its ownK190734 Linshom Respiratory Monitoring Device (LRMD)Linshom Management, LLC · 2020
- Descendant · 4 generations on · 2 of its ownK173181 ExSpiron 1XiRespiratory Motion, Inc. · 2018
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K120087ExspironRespiratory Motion, Inc. · 2012 · cites it directly8descendants
- K130170Exspiron 1XIRespiratory Motion, Inc. · 2013 · 2 generations on4descendants
- K162131ExSpiron 1XiRespiratory Motion, Inc. · 2017 · 3 generations on3descendants
- K190734Linshom Respiratory Monitoring Device (LRMD)Linshom Management, LLC · 2020 · 2 generations on2descendants
- K173181ExSpiron 1XiRespiratory Motion, Inc. · 2018 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K091853 | Wright Respirometer, Mark 8, and 14 Respirometer, Model 700-021, 700-008… | Nspire Health, Inc. | 2009 | — |
| +1 | K120087 | Exspiron | Respiratory Motion, Inc. | 2012 | — |
| +2 | K130170 | Exspiron 1XI | Respiratory Motion, Inc. | 2013 | — |
| +3 | K162131 | ExSpiron 1Xi | Respiratory Motion, Inc. | 2017 | — |
| +2 | K190734 | Linshom Respiratory Monitoring Device (LRMD) | Linshom Management, LLC | 2020 | — |
| +4 | K173181 | ExSpiron 1Xi | Respiratory Motion, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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 BZK? 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 BZK device
- #1 K260226 ElintMAX Respiratory Monitor (ElintMAX Monitor…score 19.5 · 26 generations · no Class I recall
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 |
|---|---|---|---|
| * | — | Boehringer Laboratories Adult Spirometer #8800 Named without a submission number |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120087 | Exspiron | 2012 | 8 |
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, K120087 (Respiratory Motion, Inc., 2012) has gone furthest, with 8 descendants of its own.
How does its category compare?
All BZK devicesBZK Spirometer, Monitoring (W/Wo Alarm): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · BZK
2in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · BZK
71in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZK
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BZK
2in 2020
MAUDE reports naming product code BZK, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 3 | 71 | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 2 | 0 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 73 |
| 2014 | 0 | — | 0 | 31 |
| 2015 | 0 | — | 0 | 12 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The intended use of the Wright/Haloscale Respirometer is the measurement and monitoring of the level of lung ventilation achieved by intensive care patients, during anesthesia and post operative recovery.
It measures expired volumes and thus indicates whether adequate ventilation is being achieved, whether in open or closed circuit or spontaneously breathing or mechanically ventilated patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091853 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091853: Wright Respirometer, Mark 8, and 14 Respirometer, Model 700-021, 700-008, 700-014.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091853
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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