510(k) · Cleared
ClearedSpirotel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mir Medical Intl. Research Srl · BZG Spirometer, Diagnostic
Cleared on Jul 19, 2005 as substantially equivalent to K031643 (Sdi Diagnostics, Inc., 2003) and 1 other predicate after a 210-day review. Its family tree reaches back 2 generations to 1994. 42 later devices descend from it.
- Decided
- Jul 19, 2005
- Review
- 210 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K943404 (1994). 6 ancestors in all. 42 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK943404 3301 Pulse OximeterBci Intl., Inc. · 1994
- 1 generation backK013171 3420 Digit Pulse Oximeter, Model 3420Bci, Inc. · 2002
- This deviceK043528 SpirotelMir Medical Intl. Research Srl · 2005
- Descendant · cites it directly · 40 of its ownK061712 Spirobank IIMir Medical Intl. Research Srl · 2006
- Descendant · 2 generations on · 33 of its ownK072979 Spirobank GMir Medical Intl. Research Srl · 2007
- Descendant · 3 generations on · 16 of its ownK191272 Wearable Device, Wearable PackageCurrent Health, Ltd. · 2019
- Descendant · 4 generations on · 8 of its ownK210133 Current Health Monitoring System Gen 2 (G2)Current Health · 2021
- Descendant · 4 generations on · 7 of its ownK221282 Empatica Health Monitoring PlatformEmpatica S.r.l. · 2022
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 42 · See all- K061712Spirobank IIMir Medical Intl. Research Srl · 2006 · cites it directly40descendants
- K072979Spirobank GMir Medical Intl. Research Srl · 2007 · 2 generations on33descendants
- K191272Wearable Device, Wearable PackageCurrent Health, Ltd. · 2019 · 3 generations on16descendants
- K210133Current Health Monitoring System Gen 2 (G2)Current Health · 2021 · 4 generations on8descendants
- K221282Empatica Health Monitoring PlatformEmpatica S.r.l. · 2022 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K943404 | 3301 Pulse Oximeter | Bci Intl., Inc. | 1994 | — |
| −1 | K013171 | 3420 Digit Pulse Oximeter, Model 3420 | Bci, Inc. | 2002 | — |
| 0 (this device) | K043528 | Spirotel | Mir Medical Intl. Research Srl | 2005 | — |
| +1 | K061712 | Spirobank II | Mir Medical Intl. Research Srl | 2006 | — |
| +2 | K072979 | Spirobank G | Mir Medical Intl. Research Srl | 2007 | — |
| +3 | K191272 | Wearable Device, Wearable Package | Current Health, Ltd. | 2019 | — |
| +4 | K210133 | Current Health Monitoring System Gen 2 (G2) | Current Health | 2021 | — |
| +4 | K221282 | Empatica Health Monitoring Platform | Empatica S.r.l. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 6 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 6 | 0 |
| 2024 | 7 | 0 |
| 2025 | 5 | 0 |
| 2026 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K031643 | Spirotel, Model 29-1020Summary page 1…ted device to which the submitter claims equivalence: Company Name: SDI Diagnostics, Inc. Device Name: Spirotel, Model 29-1020. 5 10(k) number: K031643 Company Name: BCl, Inc. Device Name: 3420 "Digit" Pulse Oximeter. 5 10(k) number: K013171 4. Descrip… | 2003 |
| * | K013171 | 3420 Digit Pulse Oximeter, Model 3420Summary page 1…Spirotel, Model 29-1020. 5 10(k) number: K031643 Company Name: BCl, Inc. Device Name: 3420 "Digit" Pulse Oximeter. 5 10(k) number: K013171 4. Description of the device: MIR Spirotel is a simple to operate precise pocket spirmeerand pulse oximeter (weight only I1O0… | 2002 |
What descends from it? (42)
See all 422 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 11 years and passes through 3 companies; a new generation was cleared every 7.2 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K061712 (Mir Medical Intl. Research Srl, 2006) has gone furthest, with 40 descendants of its own.
- 1 other device also cites its predicate K031643.
How does its category compare?
All BZG devicesBZG Spirometer, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Spirotel spirometer and pulse oximeter is intended to be used by a physician or by a patient under the instruction of a physician or paramedic to test lung function in people of all ages. It is also intended to be used as a single-patient device and can be used in any setting - home, factory, pharmacy, hospital or physician's office.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043528 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043528: Spirotel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043528
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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