510(k) · Cleared
ClearedModification to: Eflow Electronic Inhaler/Nebulizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pari Innovative Manufacturers, Inc. · CAF Nebulizer (Direct Patient Interface)
Cleared on Dec 13, 2007 as substantially equivalent to K033833 (Pari Innovative Manufacturers, Inc., 2004) after an 83-day review. Its family tree reaches back 3 generations to 1997. 5 later devices descend from it.
- Decided
- Dec 13, 2007
- Review
- 83 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K970010 (1997). 5 ancestors in all, the oldest K963924 (1996). 5 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK970010 FPT NebulizerFluid Propulsion Technologies, Inc. · 1997
- 2 generations backK992831 Aeroneb II, Model Apn 200Aerogen, Inc. · 2000
- 1 generation backK033833 Eflow Electronic Inhaler/NebulizerPari Innovative Manufacturers, Inc. · 2004
- This deviceK072670 Modification to: Eflow Electronic Inhaler/NebulizerPari Innovative Manufacturers, Inc. · 2007
- Descendant · cites it directly · 4 of its ownK100380 Altera Nebulizer System, Model 678G1002Pari Respiratory Equipment, Inc. · 2010
- Descendant · cites it directly · 3 of its ownK112859 Erapid Nebulizer SystemPari Respiratory Equipment, Inc. · 2012
- Descendant · 2 generations on · 1 of its ownK223840 eRapid Nebulizer SystemPari Respiratory Equipment, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK251572 eRapid with eTrack SystemPari Respiratory Equipment, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK162785 Velox Nebulizer SystemPari Respiratory Equipment, Inc. · 2017
Most influential descendants
Showing 5 of 5 · See all- K100380Altera Nebulizer System, Model 678G1002Pari Respiratory Equipment, Inc. · 2010 · cites it directly4descendants
- K112859Erapid Nebulizer SystemPari Respiratory Equipment, Inc. · 2012 · cites it directly3descendants
- K223840eRapid Nebulizer SystemPari Respiratory Equipment, Inc. · 2023 · 2 generations on1descendant
- K251572eRapid with eTrack SystemPari Respiratory Equipment, Inc. · 2025 · 3 generations on0descendants
- K162785Velox Nebulizer SystemPari Respiratory Equipment, Inc. · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K970010 | FPT Nebulizer | Fluid Propulsion Technologies, Inc. | 1997 | — |
| −2 | K992831 | Aeroneb II, Model Apn 200 | Aerogen, Inc. | 2000 | — |
| −1 | K033833 | Eflow Electronic Inhaler/Nebulizer | Pari Innovative Manufacturers, Inc. | 2004 | — |
| 0 (this device) | K072670 | Modification to: Eflow Electronic Inhaler/Nebulizer | Pari Innovative Manufacturers, Inc. | 2007 | — |
| +1 | K100380 | Altera Nebulizer System, Model 678G1002 | Pari Respiratory Equipment, Inc. | 2010 | — |
| +1 | K112859 | Erapid Nebulizer System | Pari Respiratory Equipment, Inc. | 2012 | — |
| +2 | K223840 | eRapid Nebulizer System | Pari Respiratory Equipment, Inc. | 2023 | — |
| +3 | K251572 | eRapid with eTrack System | Pari Respiratory Equipment, Inc. | 2025 | — |
| +2 | K162785 | Velox Nebulizer System | Pari Respiratory Equipment, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 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? (1)
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 |
|---|---|---|---|
| * | K033833 | Eflow Electronic Inhaler/NebulizerSummary page 2…he eFlow® device are substantially equivalent to the eFlow® Electronic Nebulizer, previously determined to be substantially equivalent on May 5, 2004 in 510k No. K033833. PARJ Special 510(k): Device Modification - eFlow® Change 2 5-2 DE… | 2004 |
What descends from it? (5)
2 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 10 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K100380 (Pari Respiratory Equipment, Inc., 2010) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K033833.
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The eFlow® is a handheld nebulizer that will be used with patients for whom doctors have prescribed medication for nebulization. The eFlow is intended for adult and pediatric patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072670 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072670: Modification to: Eflow Electronic Inhaler/Nebulizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072670
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