510(k) · Cleared
ClearedSalter Aire Compressor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Salter Labs · CAF Nebulizer (Direct Patient Interface)
Cleared on Jan 7, 2000 as substantially equivalent to K964078 (Medical Industries America, Inc., 1997) and 1 other predicate after a 184-day review. Its family tree reaches back 1 generation to 1995. 3 later devices descend from it.
- Decided
- Jan 7, 2000
- Review
- 184 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K942444 (1995). 2 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK942444 3002 AeromaxMedical Industries America, Inc. · 1995
- This deviceK992285 Salter Aire CompressorSalter Labs · 2000
- Descendant · cites it directly · 0 of its ownK082878 Nevoni Classic, Model 6600-PONsr Comercio E Representacoes Ltda · 2008
- Descendant · cites it directly · 0 of its ownK072163 Happyneb II, Happyneb Iii, Speedy, Nebby Plus and Myneb, Model 53A Health Care S.R.L. · 2008
- Descendant · cites it directly · 0 of its ownK062014 Families of Master Neb, Primo Neb, SC03, Neb Aid, 4.2.Neb, Q03…Flaem Nuova S.P.A. · 2007
Most influential descendants
Showing 3 of 3 · See all- K082878Nevoni Classic, Model 6600-PONsr Comercio E Representacoes Ltda · 2008 · cites it directly0descendants
- K072163Happyneb II, Happyneb Iii, Speedy, Nebby Plus and Myneb, Model 53A Health Care S.R.L. · 2008 · cites it directly0descendants
- K062014Families of Master Neb, Primo Neb, SC03, Neb Aid, 4.2.Neb, Q03, FJ03, and Walkie-NebFlaem Nuova S.P.A. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K942444 | 3002 Aeromax | Medical Industries America, Inc. | 1995 | — |
| 0 (this device) | K992285 | Salter Aire Compressor | Salter Labs | 2000 | — |
| +1 | K082878 | Nevoni Classic, Model 6600-PO | Nsr Comercio E Representacoes Ltda | 2008 | — |
| +1 | K072163 | Happyneb II, Happyneb Iii, Speedy, Nebby Plus and Myneb, Model 5 | 3A Health Care S.R.L. | 2008 | — |
| +1 | K062014 | Families of Master Neb, Primo Neb, SC03, Neb Aid, 4.2.Neb, Q03, FJ03, and… | Flaem Nuova S.P.A. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K964078 | 3050 Sport-NebSummary page 3…ter Labs 510(k) Submission for Salter Aire Compressor 29 b. Predicate Devices: Product: Manufacturer: 510(k) Number: Sport-Neb Medical Industry America K964078 Aeromax Medical Industry America K942444 Table 3.1 Predicate Devices ¢. Comparative Product Matrix The chart below compares Sa… | 1997 |
| * | K942444 | 3002 AeromaxSummary page 3…e Compressor 29 b. Predicate Devices: Product: Manufacturer: 510(k) Number: Sport-Neb Medical Industry America K964078 Aeromax Medical Industry America K942444 Table 3.1 Predicate Devices ¢. Comparative Product Matrix The chart below compares Salter Aire Compressor with predicate devic… | 1995 |
What descends from it? (3)
3 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?
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 Salter Aire Compressor is an AC-powered, piston type air compressor that generates pressurized air for use with a small volume nebulizer to produce an aerosol. This product is intended to be used primarily by patients in the home care market, although it may also be used by trained hospital staff personnel as well.
The Salter Aire Compressor is a prescription use, non-sterile, durable device.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992285 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992285: Salter Aire Compressor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992285
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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