510(k) · Cleared
ClearedSpiro Pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Erich Jaeger GmbH · BTY Calculator, Predicted Values, Pulmonary Function
Cleared on Mar 29, 2000 after a 30-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 12 later devices descend from it.
- Decided
- Mar 29, 2000
- Review
- 30 days
- Class
- Class II
- Product code
- BTY
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 2 citing it directly.
- This deviceK000648 Spiro ProErich Jaeger GmbH · 2000
- Descendant · cites it directly · 10 of its ownK031515 Spiropro SPO2Viasys Healthcare GmbH · 2003
- Descendant · 2 generations on · 9 of its ownK092324 SpiroproViasys Healthcare GmbH · 2009
- Descendant · 3 generations on · 6 of its ownK100687 Vitalograph Hand Held Spirometer, Model 2120Vitalograph (Ireland), Ltd. · 2010
- Descendant · 4 generations on · 2 of its ownK200550 Vitalograph Model 2120 In2itive eDiaryVitalograph Ireland, Ltd. · 2020
- Descendant · 5 generations on · 1 of its ownK212938 Vitalograph Model 6000 AlphaVitalograph Ireland, Ltd. · 2022
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K031515Spiropro SPO2Viasys Healthcare GmbH · 2003 · cites it directly10descendants
- K092324SpiroproViasys Healthcare GmbH · 2009 · 2 generations on9descendants
- K100687Vitalograph Hand Held Spirometer, Model 2120Vitalograph (Ireland), Ltd. · 2010 · 3 generations on6descendants
- K200550Vitalograph Model 2120 In2itive eDiaryVitalograph Ireland, Ltd. · 2020 · 4 generations on2descendants
- K212938Vitalograph Model 6000 AlphaVitalograph Ireland, Ltd. · 2022 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000648 | Spiro Pro | Erich Jaeger GmbH | 2000 | — |
| +1 | K031515 | Spiropro SPO2 | Viasys Healthcare GmbH | 2003 | — |
| +2 | K092324 | Spiropro | Viasys Healthcare GmbH | 2009 | — |
| +3 | K100687 | Vitalograph Hand Held Spirometer, Model 2120 | Vitalograph (Ireland), Ltd. | 2010 | — |
| +4 | K200550 | Vitalograph Model 2120 In2itive eDiary | Vitalograph Ireland, Ltd. | 2020 | — |
| +5 | K212938 | Vitalograph Model 6000 Alpha | Vitalograph Ireland, Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BTY? 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 BTY device
- #1 K260242 CPETWise Platformscore 13.1 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (12)
See all 122 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?
- Of its descendants, K031515 (Viasys Healthcare GmbH, 2003) has gone furthest, with 10 descendants of its own.
How does its category compare?
All BTY devicesBTY Calculator, Predicted Values, Pulmonary Function: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BTY
3in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · BTY
266in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTY
2in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BTY
5in 2024
MAUDE reports naming product code BTY, 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 | 2 | — | 0 | 0 |
| 2008 | 3 | 104 | 0 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 3 |
| 2012 | 3 | 139 | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 1 | 1 |
| 2015 | 0 | — | 0 | 51 |
| 2016 | 1 | — | 0 | 24 |
| 2017 | 1 | — | 2 | 9 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 2 | — | 0 | 3 |
| 2020 | 1 | — | 0 | 3 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 3 | 266 | 0 | 5 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K000648 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000648: Spiro Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000648
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026