510(k) · Cleared
ClearedKoko Spirometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ferraris Respiratory, Inc. · BZG Spirometer, Diagnostic
Cleared on Jul 2, 1992 after a 282-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 14 later devices descend from it.
- Decided
- Jul 2, 1992
- Review
- 282 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 2 citing it directly.
- This deviceK914272 Koko SpirometerFerraris Respiratory, Inc. · 1992
- Descendant · cites it directly · 7 of its ownK051572 Koko LegendPulmonary Data Services, Inc. · 2005
- Descendant · 2 generations on · 6 of its ownK100687 Vitalograph Hand Held Spirometer, Model 2120Vitalograph (Ireland), Ltd. · 2010
- Descendant · cites it directly · 5 of its ownK973314 Spirosafe FilterMicro Direct, Inc. · 1997
- Descendant · 3 generations on · 2 of its ownK200550 Vitalograph Model 2120 In2itive eDiaryVitalograph Ireland, Ltd. · 2020
- Descendant · 2 generations on · 2 of its ownK043148 All Flow Pulmonary Function FilterAlliance Tech Medical, Inc. · 2004 · Recalled
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K051572Koko LegendPulmonary Data Services, Inc. · 2005 · cites it directly7descendants
- K100687Vitalograph Hand Held Spirometer, Model 2120Vitalograph (Ireland), Ltd. · 2010 · 2 generations on6descendants
- K973314Spirosafe FilterMicro Direct, Inc. · 1997 · cites it directly5descendants
- K200550Vitalograph Model 2120 In2itive eDiaryVitalograph Ireland, Ltd. · 2020 · 3 generations on2descendants
- K043148All Flow Pulmonary Function FilterAlliance Tech Medical, Inc. · 2004 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K914272 | Koko Spirometer | Ferraris Respiratory, Inc. | 1992 | — |
| +1 | K051572 | Koko Legend | Pulmonary Data Services, Inc. | 2005 | — |
| +2 | K100687 | Vitalograph Hand Held Spirometer, Model 2120 | Vitalograph (Ireland), Ltd. | 2010 | — |
| +1 | K973314 | Spirosafe Filter | Micro Direct, Inc. | 1997 | — |
| +3 | K200550 | Vitalograph Model 2120 In2itive eDiary | Vitalograph Ireland, Ltd. | 2020 | — |
| +2 | K043148 | All Flow Pulmonary Function Filter | Alliance Tech Medical, Inc. | 2004 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 2 | 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 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (14)
See all 142 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, K051572 (Pulmonary Data Services, Inc., 2005) has gone furthest, with 7 descendants of its own.
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 | — |
https://510kreport.com/device/K914272 · printed Nov 6, 2026
Cite this page
510(k) Report. “K914272: Koko Spirometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K914272
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026