510(k) · Cleared
ClearedSpiropro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Viasys Healthcare GmbH · DQA Oximeter
Cleared on Sep 3, 2009 as substantially equivalent to K031515 (Viasys Healthcare GmbH, 2003) and 1 other predicate after a 30-day review. Its family tree reaches back 2 generations to 2000. 9 later devices descend from it.
- Decided
- Sep 3, 2009
- Review
- 30 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K000648 (2000). 5 ancestors in all, the oldest K980876 (1998). 9 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK000648 Spiro ProErich Jaeger GmbH · 2000
- 1 generation backK031515 Spiropro SPO2Viasys Healthcare GmbH · 2003
- This deviceK092324 SpiroproViasys Healthcare GmbH · 2009
- Descendant · cites it directly · 6 of its ownK100687 Vitalograph Hand Held Spirometer, Model 2120Vitalograph (Ireland), Ltd. · 2010
- Descendant · 2 generations on · 2 of its ownK200550 Vitalograph Model 2120 In2itive eDiaryVitalograph Ireland, Ltd. · 2020
- Descendant · 3 generations on · 1 of its ownK212938 Vitalograph Model 6000 AlphaVitalograph Ireland, Ltd. · 2022
- Descendant · 2 generations on · 1 of its ownK142812 Vitalograph Model 6800 PneumotracVitalograph (Ireland), Ltd. · 2015
- Descendant · 4 generations on · 0 of its ownK251777 MESI mTABLET SPIROMesi D.O.O. · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K100687Vitalograph Hand Held Spirometer, Model 2120Vitalograph (Ireland), Ltd. · 2010 · cites it directly6descendants
- K200550Vitalograph Model 2120 In2itive eDiaryVitalograph Ireland, Ltd. · 2020 · 2 generations on2descendants
- K212938Vitalograph Model 6000 AlphaVitalograph Ireland, Ltd. · 2022 · 3 generations on1descendant
- K142812Vitalograph Model 6800 PneumotracVitalograph (Ireland), Ltd. · 2015 · 2 generations on1descendant
- K251777MESI mTABLET SPIROMesi D.O.O. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000648 | Spiro Pro | Erich Jaeger GmbH | 2000 | — |
| −1 | K031515 | Spiropro SPO2 | Viasys Healthcare GmbH | 2003 | — |
| 0 (this device) | K092324 | Spiropro | Viasys Healthcare GmbH | 2009 | — |
| +1 | K100687 | Vitalograph Hand Held Spirometer, Model 2120 | Vitalograph (Ireland), Ltd. | 2010 | — |
| +2 | K200550 | Vitalograph Model 2120 In2itive eDiary | Vitalograph Ireland, Ltd. | 2020 | — |
| +3 | K212938 | Vitalograph Model 6000 Alpha | Vitalograph Ireland, Ltd. | 2022 | — |
| +2 | K142812 | Vitalograph Model 6800 Pneumotrac | Vitalograph (Ireland), Ltd. | 2015 | — |
| +4 | K251777 | MESI mTABLET SPIRO | Mesi D.O.O. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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 DQA? 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 DQA device
- #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 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 |
|---|---|---|---|
| * | K031515 | Spiropro SPO2Summary page 2…) Paradigm" -- Additional data transfer to computer by blue tooth -- 5.9 Legally predicate marketed device * SpiroPro SpO2 K031515 / Code DQA, BTY AM1+/AMI+BT K090486 / Code BZG. 5.10 Predicate Device Company Ca… | 2003 |
| * | K090486 | Asthma Monitor Model, AM1Summary page 2…tooth -- 5.9 Legally predicate marketed device * SpiroPro SpO2 K031515 / Code DQA, BTY AM1+/AMI+BT K090486 / Code BZG. 5.10 Predicate Device Company Cardinal Health Germany 234 GmbH 5.11 Device Description Sp… | 2009 |
| † | K030004 | 0.55% Orth-Phthalaldehyde Solution | 2003 |
What descends from it? (9)
3 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 9 years and passes through 2 companies; a new generation was cleared every 5.8 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K100687 (Vitalograph (Ireland), Ltd., 2010) has gone furthest, with 6 descendants of its own.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · DQA
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQA
182in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQA
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQA
399in 2025
MAUDE reports naming product code DQA, 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 | 20 | 122 | 6 | 325 |
| 2008 | 22 | 97 | 5 | 312 |
| 2009 | 35 | 117 | 29 | 281 |
| 2010 | 29 | 127 | 4 | 185 |
| 2011 | 15 | 195 | 1 | 164 |
| 2012 | 14 | 120 | 0 | 322 |
| 2013 | 15 | 182 | 0 | 468 |
| 2014 | 11 | 175 | 2 | 1,124 |
| 2015 | 13 | 158 | 1 | 2,082 |
| 2016 | 14 | 246 | 0 | 1,775 |
| 2017 | 9 | 200 | 0 | 1,190 |
| 2018 | 18 | 260 | 32 | 694 |
| 2019 | 19 | 158 | 0 | 548 |
| 2020 | 15 | 126 | 0 | 426 |
| 2021 | 10 | 174 | 0 | 553 |
| 2022 | 20 | 265 | 0 | 478 |
| 2023 | 13 | 317 | 0 | 392 |
| 2024 | 14 | 285 | 3 | 545 |
| 2025 | 15 | 182 | 0 | 399 |
| 2026 | 8 | 187 | 0 | — |
What is it indicated for?
The SpiroPro is a portable, battery operated device and can be used by physicians in the office or hospital, in occupational medicine or by patients in the home. The SpiroPro measures inspiratory and expiratory lung function parameters in adults and children 4 years and older. In addition to the pulmonary function measurements, oxygen saturation and heart rate can be recorded.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092324 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092324: Spiropro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092324
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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