510(k) · Cleared
ClearedSalter Labs Nebulizer Exhalation Aerosol Filter
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 Dec 17, 1998 as substantially equivalent to K926455 (Paul Ritzau Pari-Werk GmbH, 1993) after an 81-day review. Its family tree reaches back 1 generation to 1993. 2 later devices descend from it.
- Decided
- Dec 17, 1998
- Review
- 81 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K926455 (1993). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK926455 Pari Filter/Valve SetPaul Ritzau Pari-Werk GmbH · 1993
- This deviceK983403 Salter Labs Nebulizer Exhalation Aerosol FilterSalter Labs · 1998
- Descendant · cites it directly · 0 of its ownK220145 Monaghan medical filtered mouthpiece kitMonaghan Medical Corporation · 2023
- Descendant · cites it directly · 0 of its ownK992986 Salter Labs Single Patient Use Exhalation Aerosol FilterSalter Labs · 1999
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K926455 | Pari Filter/Valve Set | Paul Ritzau Pari-Werk GmbH | 1993 | — |
| 0 (this device) | K983403 | Salter Labs Nebulizer Exhalation Aerosol Filter | Salter Labs | 1998 | — |
| +1 | K220145 | Monaghan medical filtered mouthpiece kit | Monaghan Medical Corporation | 2023 | — |
| +1 | K992986 | Salter Labs Single Patient Use Exhalation Aerosol Filter | Salter Labs | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K926455 | Pari Filter/Valve SetSummary page 1…xhalation Aerosol Filter Common Name is Exhalation Filter Classification Name: Breathing Circuit Bacterial Filter 3) Substantially equivalent to Pari Exhalation Filter, K926455. 4) Device Description and System Overview: The Salter Labs Aerosol Filter is designed to connect to the exhalation valve of the… | 1993 |
What descends from it? (2)
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?
- Its one ancestor has no recall.
- Of its descendants, K220145 (Monaghan Medical Corporation, 2023) has gone furthest, with 0 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?
This product is indicated for use whenever the physician or healthcare professional administering or prescribing medical aerosol products to a patient with a Salter Labs nebulizer wishes to minimize the amount of medical aerosol exhaled into the air.
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/K983403 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983403: Salter Labs Nebulizer Exhalation Aerosol Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983403
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