510(k) · Cleared
ClearedGoSpiro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Monitored Therapeutics, Inc. · BZG Spirometer, Diagnostic
Cleared on Mar 24, 2017 as substantially equivalent to K072979 (Mir Medical Intl. Research Srl, 2007) after a 126-day review. Its family tree reaches back 5 generations to 1994. 2 later devices descend from it.
- Decided
- Mar 24, 2017
- Review
- 126 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K943404 (1994). 10 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK943404 3301 Pulse OximeterBci Intl., Inc. · 1994
- 4 generations backK013171 3420 Digit Pulse Oximeter, Model 3420Bci, Inc. · 2002
- 3 generations backK043528 SpirotelMir Medical Intl. Research Srl · 2005
- 2 generations backK061712 Spirobank IIMir Medical Intl. Research Srl · 2006
- 1 generation backK072979 Spirobank GMir Medical Intl. Research Srl · 2007
- This deviceK163249 GoSpiroMonitored Therapeutics, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK213754 SpiroHome Personal, SpiroHome ClinicInofab Saglik Teknolojileri A.S · 2023
- Descendant · cites it directly · 0 of its ownK202837 GoSpiroMonitored Therapeutics, Inc. · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K943404 | 3301 Pulse Oximeter | Bci Intl., Inc. | 1994 | — |
| −4 | K013171 | 3420 Digit Pulse Oximeter, Model 3420 | Bci, Inc. | 2002 | — |
| −3 | K043528 | Spirotel | Mir Medical Intl. Research Srl | 2005 | — |
| −2 | K061712 | Spirobank II | Mir Medical Intl. Research Srl | 2006 | — |
| −1 | K072979 | Spirobank G | Mir Medical Intl. Research Srl | 2007 | — |
| 0 (this device) | K163249 | GoSpiro | Monitored Therapeutics, Inc. | 2017 | — |
| +1 | K213754 | SpiroHome Personal, SpiroHome Clinic | Inofab Saglik Teknolojileri A.S | 2023 | — |
| +1 | K202837 | GoSpiro | Monitored Therapeutics, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 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 BZG? 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 BZG device
- #1 K251777 MESI mTABLET SPIROscore 13.0 · 8 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.
What descends from it? (2)
2 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?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K213754 (Inofab Saglik Teknolojileri A.S, 2023) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K072979.
How does its category compare?
All BZG devicesBZG Spirometer, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · BZG
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · BZG
362in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZG
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BZG
1in 2025
MAUDE reports naming product code BZG, 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 | 3 | 121 | 0 | 1 |
| 2008 | 3 | 209 | 0 | 0 |
| 2009 | 8 | 141 | 0 | 0 |
| 2010 | 4 | 181 | 0 | 0 |
| 2011 | 6 | 278 | 0 | 1 |
| 2012 | 3 | 59 | 0 | 2 |
| 2013 | 3 | 266 | 0 | 1 |
| 2014 | 5 | 154 | 0 | 1 |
| 2015 | 5 | 273 | 0 | 1 |
| 2016 | 4 | 235 | 0 | 1 |
| 2017 | 2 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 3 | 146 | 0 | 1 |
| 2020 | 5 | 126 | 0 | 2 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 2 | — | 0 | 3 |
| 2023 | 5 | 362 | 0 | 2 |
| 2024 | 2 | — | 1 | 3 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The GoSpiro® is intended to be used by adults and children over 5 years old in physician’s offices, clinics and home settings to conduct basic lung function and spirometry testing. It is a single-patient use device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163249 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163249: GoSpiro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163249
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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