510(k) · Cleared
ClearedFPT Nebulizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fluid Propulsion Technologies, Inc. · CAF Nebulizer (Direct Patient Interface)
Cleared on Apr 1, 1997 after an 89-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 15 later devices descend from it.
- Decided
- Apr 1, 1997
- Review
- 89 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 3 citing it directly.
- This deviceK970010 FPT NebulizerFluid Propulsion Technologies, Inc. · 1997
- Descendant · cites it directly · 11 of its ownK992831 Aeroneb II, Model Apn 200Aerogen, Inc. · 2000
- Descendant · 2 generations on · 10 of its ownK033833 Eflow Electronic Inhaler/NebulizerPari Innovative Manufacturers, Inc. · 2004
- Descendant · 3 generations on · 5 of its ownK072670 Modification to: Eflow Electronic Inhaler/NebulizerPari Innovative Manufacturers, Inc. · 2007
- Descendant · 3 generations on · 4 of its ownK100380 Altera Nebulizer System, Model 678G1002Pari Respiratory Equipment, Inc. · 2010
- Descendant · 3 generations on · 3 of its ownK112859 Erapid Nebulizer SystemPari Respiratory Equipment, Inc. · 2012
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K992831Aeroneb II, Model Apn 200Aerogen, Inc. · 2000 · cites it directly11descendants
- K033833Eflow Electronic Inhaler/NebulizerPari Innovative Manufacturers, Inc. · 2004 · 2 generations on10descendants
- K072670Modification to: Eflow Electronic Inhaler/NebulizerPari Innovative Manufacturers, Inc. · 2007 · 3 generations on5descendants
- K100380Altera Nebulizer System, Model 678G1002Pari Respiratory Equipment, Inc. · 2010 · 3 generations on4descendants
- K112859Erapid Nebulizer SystemPari Respiratory Equipment, Inc. · 2012 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970010 | FPT Nebulizer | Fluid Propulsion Technologies, Inc. | 1997 | — |
| +1 | K992831 | Aeroneb II, Model Apn 200 | Aerogen, Inc. | 2000 | — |
| +2 | K033833 | Eflow Electronic Inhaler/Nebulizer | Pari Innovative Manufacturers, Inc. | 2004 | — |
| +3 | K072670 | Modification to: Eflow Electronic Inhaler/Nebulizer | Pari Innovative Manufacturers, Inc. | 2007 | — |
| +3 | K100380 | Altera Nebulizer System, Model 678G1002 | Pari Respiratory Equipment, Inc. | 2010 | — |
| +3 | K112859 | Erapid Nebulizer System | Pari Respiratory Equipment, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 CAF? 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 CAF device
- #1 K260270 FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)score 13.2 · 7 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? (15)
See all 153 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, K992831 (Aerogen, Inc., 2000) has gone furthest, with 11 descendants of its own.
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CAF
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CAF
211in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CAF
1in 2018
Class I (13 since 2007) Class II/III not classified
Adverse event reports per year · CAF
191in 2025
MAUDE reports naming product code CAF, 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 | 18 | 98 | 1 | 26 |
| 2008 | 12 | 123 | 0 | 11 |
| 2009 | 8 | 163 | 0 | 15 |
| 2010 | 10 | 114 | 0 | 37 |
| 2011 | 10 | 157 | 1 | 237 |
| 2012 | 9 | 126 | 0 | 138 |
| 2013 | 9 | 238 | 0 | 217 |
| 2014 | 9 | 151 | 5 | 123 |
| 2015 | 8 | 186 | 3 | 166 |
| 2016 | 5 | 186 | 1 | 201 |
| 2017 | 8 | 253 | 14 (13) | 256 |
| 2018 | 9 | 161 | 1 | 162 |
| 2019 | 3 | 266 | 0 | 185 |
| 2020 | 6 | 219 | 0 | 117 |
| 2021 | 8 | 324 | 0 | 161 |
| 2022 | 4 | 176 | 0 | 55 |
| 2023 | 8 | 279 | 0 | 107 |
| 2024 | 4 | 251 | 0 | 102 |
| 2025 | 7 | 211 | 0 | 191 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K970010 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970010: FPT Nebulizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970010
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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