510(k) · Cleared
ClearedEflow 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 May 5, 2004 as substantially equivalent to K992831 (Aerogen, Inc., 2000) and 2 other predicates after a 147-day review. Its family tree reaches back 2 generations to 1997. 10 later devices descend from it.
- Decided
- May 5, 2004
- Review
- 147 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K970010 (1997). 4 ancestors in all, the oldest K963924 (1996). 10 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK970010 FPT NebulizerFluid Propulsion Technologies, Inc. · 1997
- 1 generation backK992831 Aeroneb II, Model Apn 200Aerogen, Inc. · 2000
- This deviceK033833 Eflow Electronic Inhaler/NebulizerPari Innovative Manufacturers, Inc. · 2004
- Descendant · cites it directly · 5 of its ownK072670 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 · cites it directly · 3 of its ownK072019 AKITA2 ApixnebActivaero America, Inc. · 2007
- Descendant · 2 generations on · 1 of its ownK223840 eRapid Nebulizer SystemPari Respiratory Equipment, Inc. · 2023
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K072670Modification to: Eflow Electronic Inhaler/NebulizerPari Innovative Manufacturers, Inc. · 2007 · cites it directly5descendants
- K100380Altera Nebulizer System, Model 678G1002Pari Respiratory Equipment, Inc. · 2010 · cites it directly4descendants
- K112859Erapid Nebulizer SystemPari Respiratory Equipment, Inc. · 2012 · cites it directly3descendants
- K072019AKITA2 ApixnebActivaero America, Inc. · 2007 · cites it directly3descendants
- K223840eRapid Nebulizer SystemPari Respiratory Equipment, Inc. · 2023 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970010 | FPT Nebulizer | Fluid Propulsion Technologies, Inc. | 1997 | — |
| −1 | K992831 | Aeroneb II, Model Apn 200 | Aerogen, Inc. | 2000 | — |
| 0 (this device) | K033833 | Eflow Electronic Inhaler/Nebulizer | Pari Innovative Manufacturers, Inc. | 2004 | — |
| +1 | 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 | — |
| +1 | K072019 | AKITA2 Apixneb | Activaero America, Inc. | 2007 | — |
| +2 | K223840 | eRapid Nebulizer System | Pari Respiratory Equipment, Inc. | 2023 | — |
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 |
|---|---|---|
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 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? (3)
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 |
|---|---|---|---|
| * | K992831 | Aeroneb II, Model Apn 200 Our reading of the summary gave K992381, FDA’s number for CO2 Gas Warmer II, Model 6-800-00 (Northgate Technologies, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “AeroNeb H1j Portable Nebulizer”. | 2000 |
| * | K003022 | Aeroneb Portable NebulizerSummary page 1…AeroGen Inc AeroNeb H1j Portable Nebulizer K992381 AeroGen Inc AeroNebTm Portable Nebulizer K003022/970010 PARI Innovative Manufacturers, Inc. PARI LC Star® nebulizer K963924 Device Description The… | 2000 |
| * | K963924 | LC Star Reusable Nebulizer 22F50 and LC Star Disposable Nebulizer 22F70Summary page 1…Inc AeroNebTm Portable Nebulizer K003022/970010 PARI Innovative Manufacturers, Inc. PARI LC Star® nebulizer K963924 Device Description The PARI eFlowTM is a small, single patient use, reusable electronic nebulizer for the inhalation… | 1996 |
What descends from it? (10)
4 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 7 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K072670 (Pari Innovative Manufacturers, Inc., 2007) has gone furthest, with 5 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 | — |
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 mid pediatric patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033833 · printed Nov 4, 2026
Cite this page
510(k) Report. “K033833: Eflow Electronic Inhaler/Nebulizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033833
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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