510(k) · Cleared
ClearedSpiroHome Personal, SpiroHome Clinic
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inofab Saglik Teknolojileri A.S · BZG Spirometer, Diagnostic
Cleared on Jun 12, 2023 as substantially equivalent to K163249 (Monitored Therapeutics, Inc., 2017) after a 559-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Jun 12, 2023
- Review
- 559 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K943404 (1994). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK943404 3301 Pulse OximeterBci Intl., Inc. · 1994
- 5 generations backK013171 3420 Digit Pulse Oximeter, Model 3420Bci, Inc. · 2002
- 4 generations backK043528 SpirotelMir Medical Intl. Research Srl · 2005
- 3 generations backK061712 Spirobank IIMir Medical Intl. Research Srl · 2006
- 2 generations backK072979 Spirobank GMir Medical Intl. Research Srl · 2007
- 1 generation backK163249 GoSpiroMonitored Therapeutics, Inc. · 2017
- This deviceK213754 SpiroHome Personal, SpiroHome ClinicInofab Saglik Teknolojileri A.S · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K943404 | 3301 Pulse Oximeter | Bci Intl., Inc. | 1994 | — |
| −5 | K013171 | 3420 Digit Pulse Oximeter, Model 3420 | Bci, Inc. | 2002 | — |
| −4 | K043528 | Spirotel | Mir Medical Intl. Research Srl | 2005 | — |
| −3 | K061712 | Spirobank II | Mir Medical Intl. Research Srl | 2006 | — |
| −2 | K072979 | Spirobank G | Mir Medical Intl. Research Srl | 2007 | — |
| −1 | K163249 | GoSpiro | Monitored Therapeutics, Inc. | 2017 | — |
| 0 (this device) | K213754 | SpiroHome Personal, SpiroHome Clinic | Inofab Saglik Teknolojileri A.S | 2023 | — |
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 |
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K163249 | GoSpiroSummary page 4…Name: Spirometer Classification Name: Diagnostic Spirometer (21 CFR 868.1840) Regulatory Class: II Product Code: BZG III. Predicate Device: GoSpiro, K163249 IV. Reference Device: EasyOne Air Spirometer, K161536 V. Device Description The SpiroHome Ultrasonic Spirometer (SUS) is a port… | 2017 |
| † | K161536 | EasyOne Air Spirometer | 2017 |
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?
- The line of descent spans 29 years and passes through 5 companies; a new generation was cleared every 6.2 years on median.
- None of the 11 ancestors has a recall.
- 1 other device also cites its predicate K163249.
How does its category compare?
All BZG devicesBZG Spirometer, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
SpiroHome is intended to be used by adults and children over 5 years old in physician's offices, clinics and home setting
to conduct basic lung function and spirometry testing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213754 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213754: SpiroHome Personal, SpiroHome Clinic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213754
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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