510(k) · Cleared
ClearedSpirobank II
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 Dec 1, 2006 as substantially equivalent to K983909 (Mir Medical Intl. Research Srl, 1998) and 1 other predicate after a 165-day review. Its family tree reaches back 3 generations to 1994. 40 later devices descend from it.
- Decided
- Dec 1, 2006
- Review
- 165 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K943404 (1994). 8 ancestors in all. 40 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK943404 3301 Pulse OximeterBci Intl., Inc. · 1994
- 2 generations backK013171 3420 Digit Pulse Oximeter, Model 3420Bci, Inc. · 2002
- 1 generation backK043528 SpirotelMir Medical Intl. Research Srl · 2005
- This deviceK061712 Spirobank IIMir Medical Intl. Research Srl · 2006
- Descendant · cites it directly · 33 of its ownK072979 Spirobank GMir Medical Intl. Research Srl · 2007
- Descendant · 2 generations on · 16 of its ownK191272 Wearable Device, Wearable PackageCurrent Health, Ltd. · 2019
- Descendant · 3 generations on · 8 of its ownK210133 Current Health Monitoring System Gen 2 (G2)Current Health · 2021
- Descendant · 3 generations on · 7 of its ownK221282 Empatica Health Monitoring PlatformEmpatica S.r.l. · 2022
- Descendant · 2 generations on · 5 of its ownK170798 Dictum HealthDictum Health, Inc. · 2017
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- K072979Spirobank GMir Medical Intl. Research Srl · 2007 · cites it directly33descendants
- K191272Wearable Device, Wearable PackageCurrent Health, Ltd. · 2019 · 2 generations on16descendants
- K210133Current Health Monitoring System Gen 2 (G2)Current Health · 2021 · 3 generations on8descendants
- K221282Empatica Health Monitoring PlatformEmpatica S.r.l. · 2022 · 3 generations on7descendants
- K170798Dictum HealthDictum Health, Inc. · 2017 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K943404 | 3301 Pulse Oximeter | Bci Intl., Inc. | 1994 | — |
| −2 | K013171 | 3420 Digit Pulse Oximeter, Model 3420 | Bci, Inc. | 2002 | — |
| −1 | K043528 | Spirotel | Mir Medical Intl. Research Srl | 2005 | — |
| 0 (this device) | K061712 | Spirobank II | Mir Medical Intl. Research Srl | 2006 | — |
| +1 | K072979 | Spirobank G | Mir Medical Intl. Research Srl | 2007 | — |
| +2 | K191272 | Wearable Device, Wearable Package | Current Health, Ltd. | 2019 | — |
| +3 | K210133 | Current Health Monitoring System Gen 2 (G2) | Current Health | 2021 | — |
| +3 | K221282 | Empatica Health Monitoring Platform | Empatica S.r.l. | 2022 | — |
| +2 | K170798 | Dictum Health | Dictum Health, Inc. | 2017 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 2 | 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 |
|---|---|---|---|
| * | K983909 | Mir Spirobank SpirometerSummary page 1…Identification of legally marketed device to which the submitter claims equivalence: Company Name: MIR. Device Name: Spirobank 51 0(k) number: K983909 Company Name: MIR. Device Name: Spirotel 5 10(k) number: K043528 4. Description of the device: MIR Sp… | 1998 |
| * | K043528 | SpirotelSummary page 1…y Name: MIR. Device Name: Spirobank 51 0(k) number: K983909 Company Name: MIR. Device Name: Spirotel 5 10(k) number: K043528 4. Description of the device: MIR Spirobank II is a spirometer and pulse oximeter, designed to facilitate the total valuation of… | 2005 |
What descends from it? (40)
See all 403 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 12 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K072979 (Mir Medical Intl. Research Srl, 2007) has gone furthest, with 33 descendants of its own.
- 1 other device also cites its predicate K983909.
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 Spirobank II spirometer and pulse oximeter is intended to be used by a physician or by a patient under the instruction of a physician or paramedic.
The device is intended to test lung function and can make:
* spirometry testing in people of all ages, excluding infants and neonates
* oximetry testing in people of all ages.
It can be used in any setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061712 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061712: Spirobank II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061712
Report an extraction error
Are you the manufacturer?
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